A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients
Study Details
Study Description
Brief Summary
The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BI 201335 for 24 weeks BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks |
Drug: BI 201335
BI 201335 for 24 weeks
Drug: PegIFN/RBV
PegIFN/RBV for 48 weeks
|
Outcome Measures
Primary Outcome Measures
- Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL [12 weeks post treatment, up to 60 weeks]
The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Secondary Outcome Measures
- Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) [24 weeks post treatment, up to 72 weeks]
Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
- Early Treatment Success (ETS) [week 4 and week 8]
ETS, defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) [Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers]
This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment. [48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS]
This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) [Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.]
This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment. [Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers]
This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.
- Occurrence of Adverse Events (Overall and by DAIDS Grade) [from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days]
This outcome measure will be presented as the percentage of subjects with any adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator. The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment.
- Occurrence of Adverse Events Leading to Treatment Discontinuation [from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days]
This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.
- Occurrence of Serious Adverse Events (SAEs) [from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days]
This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.
- Occurrence of Drug-related AEs as Assessed by the Investigator [from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days]
This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.
- Laboratory Test Abnormalities by DAIDS Grades [baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study]
This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.
- Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin] [baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)]
This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure Haemoglobin is presented.
- Changes From Baseline in Laboratory Test Values Over Time [ALT] [baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)]
This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure ALT is presented.
- Changes From Baseline in Laboratory Test Values Over Time [AST] [baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)]
This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure AST is presented.
- Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total] [baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)]
This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure Bilirubin total is presented.
Eligibility Criteria
Criteria
Inclusion criteria:
Chronic hepatitis C infection of GT-1 in patients who failed prior treatment with PegIFN and RBV in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program.
-
Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment [EOT]).
-
Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
-
Female patients:
-
with documented hysterectomy,
-
who have had both ovaries removed,
-
with documented tubal ligation,
-
who are post-menopausal with last menstrual period at least 12 months prior to screening, or
-
of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of RBV in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of RBV.
Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, intra-uterine device and cervical cap.
or
Male patients:
-
who are documented to be sterile, or
-
who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).
- Signed informed consent form prior to trial participation.
Exclusion criteria:
-
Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criteria.
-
HIV co-infection
-
Hepatitis B virus (HBV) infection based on presence of HBs-Ag
-
Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
-
Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
-
A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patients ability to participate in this study
-
Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
-
Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
-
Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to enrolment and throughout the treatment phase of this trial.
-
Known hypersensitivity to any ingredient of the study drugs.
-
Alpha fetoprotein value > 100 ng/mL at screening; if > 20 ng/mL and = 100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).
Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1220.48.0004 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 2 | 1220.48.0091 Boehringer Ingelheim Investigational Site | North Little Rock | Arkansas | United States | |
| 3 | 1220.48.0011 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 4 | 1220.48.0018 Boehringer Ingelheim Investigational Site | Oceanside | California | United States | |
| 5 | 1220.48.0078 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States | |
| 6 | 1220.48.0095 Boehringer Ingelheim Investigational Site | Palm Harbor | Florida | United States | |
| 7 | 1220.48.0039 Boehringer Ingelheim Investigational Site | Columbus | Georgia | United States | |
| 8 | 1220.48.0013 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 9 | 1220.48.0087 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | United States | |
| 10 | 1220.48.0027 Boehringer Ingelheim Investigational Site | Framingham | Massachusetts | United States | |
| 11 | 1220.48.0065 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | United States | |
| 12 | 1220.48.0023 Boehringer Ingelheim Investigational Site | Tupelo | Mississippi | United States | |
| 13 | 1220.48.0066 Boehringer Ingelheim Investigational Site | Neptune | New Jersey | United States | |
| 14 | 1220.48.0012 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 15 | 1220.48.0058 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States | |
| 16 | 1220.48.0063 Boehringer Ingelheim Investigational Site | Arlington | Texas | United States | |
| 17 | 1220.48.0029 Boehringer Ingelheim Investigational Site | Austin | Texas | United States | |
| 18 | 1220.48.0017 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 19 | 1220.48.0071 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 20 | 1220.48.0081 Boehringer Ingelheim Investigational Site | Forth Worth | Texas | United States | |
| 21 | 1220.48.4301 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 22 | 1220.48.4302 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 23 | 1220.48.3201 Boehringer Ingelheim Investigational Site | Bruxelles | Belgium | ||
| 24 | 1220.48.3204 Boehringer Ingelheim Investigational Site | Edegem | Belgium | ||
| 25 | 1220.48.3203 Boehringer Ingelheim Investigational Site | Liège | Belgium | ||
| 26 | 1220.48.1012 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada | |
| 27 | 1220.48.1003 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 28 | 1220.48.1016 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 29 | 1220.48.1007 Boehringer Ingelheim Investigational Site | Victoria | British Columbia | Canada | |
| 30 | 1220.48.1009 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba | Canada | |
| 31 | 1220.48.1005 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada | |
| 32 | 1220.48.1006 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada | |
| 33 | 1220.48.3301 Boehringer Ingelheim Investigational Site | Clichy Cedex | France | ||
| 34 | 1220.48.3311 Boehringer Ingelheim Investigational Site | Lille Cedex | France | ||
| 35 | 1220.48.3303 Boehringer Ingelheim Investigational Site | Marseille Cedex 08 | France | ||
| 36 | 1220.48.3304 Boehringer Ingelheim Investigational Site | Montpellier Cedex 5 | France | ||
| 37 | 1220.48.3305 Boehringer Ingelheim Investigational Site | Nice Cedex 3 | France | ||
| 38 | 1220.48.3316 Boehringer Ingelheim Investigational Site | Pessac Cedex | France | ||
| 39 | 1220.48.3312 Boehringer Ingelheim Investigational Site | Saint Laurent du Var | France | ||
| 40 | 1220.48.4902 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 41 | 1220.48.4904 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 42 | 1220.48.4913 Boehringer Ingelheim Investigational Site | Dortmund | Germany | ||
| 43 | 1220.48.4906 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany | ||
| 44 | 1220.48.4901 Boehringer Ingelheim Investigational Site | Frankfurt am Main | Germany | ||
| 45 | 1220.48.4908 Boehringer Ingelheim Investigational Site | Hamburg | Germany | ||
| 46 | 1220.48.4914 Boehringer Ingelheim Investigational Site | Kiel | Germany | ||
| 47 | 1220.48.4911 Boehringer Ingelheim Investigational Site | Mainz | Germany | ||
| 48 | 1220.48.4905 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 49 | 1220.48.8106 Boehringer Ingelheim Investigational Site | Chiba, Chiba | Japan | ||
| 50 | 1220.48.8117 Boehringer Ingelheim Investigational Site | Kita-gun, Kagawa | Japan | ||
| 51 | 1220.48.8116 Boehringer Ingelheim Investigational Site | Kurashiki, Okayama | Japan | ||
| 52 | 1220.48.8118 Boehringer Ingelheim Investigational Site | Kurume, Fukuoka | Japan | ||
| 53 | 1220.48.8113 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan | ||
| 54 | 1220.48.8114 Boehringer Ingelheim Investigational Site | Nishinomiya, Hyogo | Japan | ||
| 55 | 1220.48.8119 Boehringer Ingelheim Investigational Site | Omura, Nagasaki | Japan | ||
| 56 | 1220.48.8121 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan | ||
| 57 | 1220.48.8204 Boehringer Ingelheim Investigational Site | Pusan | Korea, Republic of | ||
| 58 | 1220.48.8205 Boehringer Ingelheim Investigational Site | Pusan | Korea, Republic of | ||
| 59 | 1220.48.8206 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 60 | 1220.48.8207 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 61 | 1220.48.8201 Boehringer Ingelheim Investigational Site | Yangsan | Korea, Republic of | ||
| 62 | 1220.48.3503 Boehringer Ingelheim Investigational Site | Aveiro | Portugal | ||
| 63 | 1220.48.3509 Boehringer Ingelheim Investigational Site | Barreiro | Portugal | ||
| 64 | 1220.48.3501 Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 65 | 1220.48.3502 Boehringer Ingelheim Investigational Site | Porto | Portugal | ||
| 66 | 1220.48.4002 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 67 | 1220.48.7001 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 68 | 1220.48.7004 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 69 | 1220.48.3406 Boehringer Ingelheim Investigational Site | A Coruña | Spain | ||
| 70 | 1220.48.3402 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 71 | 1220.48.3404 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 72 | 1220.48.3411 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 73 | 1220.48.3412 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 74 | 1220.48.3405 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 75 | 1220.48.3409 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 76 | 1220.48.3410 Boehringer Ingelheim Investigational Site | Majadahonda-Madrid | Spain | ||
| 77 | 1220.48.3403 Boehringer Ingelheim Investigational Site | Sevilla | Spain | ||
| 78 | 1220.48.3401 Boehringer Ingelheim Investigational Site | Valencia | Spain | ||
| 79 | 1220.48.4106 Boehringer Ingelheim Investigational Site | Bern | Switzerland | ||
| 80 | 1220.48.8802 China Medical University Hospital | Taichung | Taiwan | ||
| 81 | 1220.48.4405 Boehringer Ingelheim Investigational Site | Bristol | United Kingdom | ||
| 82 | 1220.48.4409 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 83 | 1220.48.4401 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom | ||
| 84 | 1220.48.4408 Boehringer Ingelheim Investigational Site | Nottingham | United Kingdom | ||
| 85 | 1220.48.4407 Boehringer Ingelheim Investigational Site | Oxford | United Kingdom | ||
| 86 | 1220.48.4403 Boehringer Ingelheim Investigational Site | Southampton | United Kingdom | ||
| 87 | 1220.48.4404 Boehringer Ingelheim Investigational Site | Tooting, London | United Kingdom |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1220.48
- 2011-000141-20
Study Results
Participant Flow
| Recruitment Details | This was a multi-national, open-label trial enrolling two cohorts of patients with chronic Hepatitis C Virus (HCV) infection of genotype 1 (GT-1) who were randomized to the placebo arm (+ Pegylated interferon α-2a/ Ribavirin) and experienced virologic failure in one of the 1220.7 (NCT01358864), 1220.30 (NCT01343888), 1220.47 (NCT01297270) trials. |
|---|---|
| Pre-assignment Detail | Eligible patients who entered the rollover trial within 14 weeks of their last study visit in one of the predecessor trials were not required to do a screening visit (treatment start: Day 1). Eligible patients who were outside of this 14-week window were required to do a screening visit (Visit 1) and started treatment at Visit 2 (Day 1). |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients. At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV. ETS is defined as Hepatitis C virus(HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8. Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser. | Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients. Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10 decrease in HCV RNA from baseline during the treatment period. Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA. Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment. |
| Period Title: Overall Study | ||
| STARTED | 43 | 75 |
| COMPLETED | 41 | 60 |
| NOT COMPLETED | 2 | 15 |
Baseline Characteristics
| Arm/Group Title | Relapse | Non-relapse | Total |
|---|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. | Total of all reporting groups |
| Overall Participants | 43 | 75 | 118 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
55.4
(7.38)
|
53.4
(9.46)
|
54.1
(8.78)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
16
37.2%
|
25
33.3%
|
41
34.7%
|
| Male |
27
62.8%
|
50
66.7%
|
77
65.3%
|
Outcome Measures
| Title | Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL |
|---|---|
| Description | The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration. |
| Time Frame | 12 weeks post treatment, up to 60 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Number (95% Confidence Interval) [percentage of participants] |
95.3
221.6%
|
54.7
72.9%
|
| Title | Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) |
|---|---|
| Description | Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. |
| Time Frame | 24 weeks post treatment, up to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Number (95% Confidence Interval) [percentage of participants] |
95.3
221.6%
|
54.7
72.9%
|
| Title | Early Treatment Success (ETS) |
|---|---|
| Description | ETS, defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8. |
| Time Frame | week 4 and week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Number [percentage of participants] |
97.7
227.2%
|
65.3
87.1%
|
| Title | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) |
|---|---|
| Description | This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment. |
| Time Frame | Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| SVR12 = Yes |
41
95.3%
|
41
54.7%
|
| SVR12 = Yes, Baseline Normal to EOT Normal |
12
27.9%
|
10
13.3%
|
| SVR12 = Yes, Baseline Elevated to EOT Normal |
16
37.2%
|
15
20%
|
| SVR12 = No |
2
4.7%
|
34
45.3%
|
| SVR12 = No, Baseline Normal to EOT Normal |
0
0%
|
11
14.7%
|
| SVR12 = No, Baseline Elevated to EOT Normal |
2
4.7%
|
9
12%
|
| Title | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment. |
|---|---|
| Description | This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment. |
| Time Frame | 48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| SVR12 = Yes |
41
95.3%
|
41
54.7%
|
| SVR12 = Yes, Baseline Normal to SVR12 Normal |
12
27.9%
|
11
14.7%
|
| SVR12 = Yes, Baseline Elevated to SVR12 Normal |
27
62.8%
|
27
36%
|
| SVR12 = No |
2
4.7%
|
34
45.3%
|
| SVR12 = No, Baseline Normal to SVR12 Normal |
0
0%
|
8
10.7%
|
| SVR12 = No, Baseline Elevated to SVR12 Normal |
1
2.3%
|
2
2.7%
|
| Title | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) |
|---|---|
| Description | This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment. |
| Time Frame | Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers. |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| SVR12 = Yes |
41
95.3%
|
41
54.7%
|
| SVR12 = Yes, Baseline Normal to EOT Normal |
15
34.9%
|
13
17.3%
|
| SVR12 = Yes, Baseline Elevated to EOT Normal |
14
32.6%
|
11
14.7%
|
| SVR12 = No |
2
4.7%
|
34
45.3%
|
| SVR12 = No, Baseline Normal to EOT Normal |
1
2.3%
|
12
16%
|
| SVR12 = No, Baseline Elevated to EOT Normal |
1
2.3%
|
7
9.3%
|
| Title | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment. |
|---|---|
| Description | This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment. |
| Time Frame | Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| SVR12 = Yes |
41
95.3%
|
41
54.7%
|
| SVR12 = Yes, Baseline Normal to SVR12 Normal |
15
34.9%
|
14
18.7%
|
| SVR12 = Yes, Baseline Elevated to SVR12 Normal |
22
51.2%
|
24
32%
|
| SVR12 = No |
2
4.7%
|
34
45.3%
|
| SVR12 = No, Baseline Normal to SVR12 Normal |
1
2.3%
|
10
13.3%
|
| SVR12 = No, Baseline Elevated to SVR12 Normal |
0
0%
|
3
4%
|
| Title | Occurrence of Adverse Events (Overall and by DAIDS Grade) |
|---|---|
| Description | This outcome measure will be presented as the percentage of subjects with any adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator. The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment. |
| Time Frame | from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Overall |
90.7
210.9%
|
93.3
124.4%
|
| Subjects with DAIDS Grade 2, 3 or 4 AEs |
65.1
151.4%
|
56.0
74.7%
|
| Subjects with DAIDS Grade 3 or 4 AEs |
27.9
64.9%
|
17.3
23.1%
|
| Subjects with DAIDS Grade 4 AEs |
7.0
16.3%
|
1.3
1.7%
|
| Title | Occurrence of Adverse Events Leading to Treatment Discontinuation |
|---|---|
| Description | This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator. |
| Time Frame | from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| discontinuation of faldaprevir |
4.7
10.9%
|
2.7
3.6%
|
| discontinuation of all study medication |
2.3
5.3%
|
0.0
0%
|
| Title | Occurrence of Serious Adverse Events (SAEs) |
|---|---|
| Description | This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator. |
| Time Frame | from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Number [percentage of participants] |
2.3
5.3%
|
8.0
10.7%
|
| Title | Occurrence of Drug-related AEs as Assessed by the Investigator |
|---|---|
| Description | This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator. |
| Time Frame | from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Number [percentage of participants] |
88.4
205.6%
|
88.0
117.3%
|
| Title | Laboratory Test Abnormalities by DAIDS Grades |
|---|---|
| Description | This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV. |
| Time Frame | baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Haemoglobin, Grade 2 |
14.0
32.6%
|
18.9
25.2%
|
| Haemoglobin, Grade 3 |
11.6
27%
|
8.1
10.8%
|
| Haemoglobin, Grade 4 |
0.0
0%
|
0.0
0%
|
| ALT, Grade 2 |
7.0
16.3%
|
6.7
8.9%
|
| ALT, Grade 3 |
2.3
5.3%
|
4.0
5.3%
|
| ALT, Grade 4 |
2.3
5.3%
|
0.0
0%
|
| AST, Grade 2 |
4.7
10.9%
|
10.7
14.3%
|
| AST, Grade 3 |
2.3
5.3%
|
2.7
3.6%
|
| AST, Grade 4 |
2.3
5.3%
|
0.0
0%
|
| Bilirubin, total, Grade 2 |
32.6
75.8%
|
37.3
49.7%
|
| Bilirubin, total, Grade 3 |
39.5
91.9%
|
29.3
39.1%
|
| Bilirubin, total, Grade 4 |
11.6
27%
|
13.3
17.7%
|
| Title | Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin] |
|---|---|
| Description | This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure Haemoglobin is presented. |
| Time Frame | baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Baseline (N=43, 74) |
14.8
(1.3)
|
14.8
(1.4)
|
| week 4 (N=41, 69) |
12.6
(1.6)
|
12.7
(1.4)
|
| week 12 (N=43, 66) |
11.7
(1.6)
|
11.5
(1.5)
|
| min value on treatment (N=43, 74) |
11.1
(1.5)
|
11.3
(1.7)
|
| max value on treatment (N=43, 74) |
13.7
(1.2)
|
14.0
(1.4)
|
| last value on treatment (N=43, 74) |
11.4
(1.5)
|
11.8
(1.6)
|
| Title | Changes From Baseline in Laboratory Test Values Over Time [ALT] |
|---|---|
| Description | This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure ALT is presented. |
| Time Frame | baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Baseline (N=43, 75) |
72
(79)
|
88
(63)
|
| week 4 (N=43, 73) |
51
(71)
|
57
(49)
|
| week 12 (N=43, 67) |
43
(40)
|
55
(62)
|
| min value on treatment (N=43, 75) |
30
(20)
|
39
(38)
|
| max value on treatment (N=43, 75) |
68
(91)
|
70
(62)
|
| last value on treatment (N=43, 75) |
40
(26)
|
54
(52)
|
| Title | Changes From Baseline in Laboratory Test Values Over Time [AST] |
|---|---|
| Description | This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure AST is presented. |
| Time Frame | baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Baseline (N=43, 75) |
54
(41)
|
68
(42)
|
| week 4 (N=43, 73) |
48
(71)
|
46
(33)
|
| week 12 (N=43, 67) |
41
(37)
|
48
(45)
|
| min value on treatment (N=43, 75) |
30
(16)
|
35
(25)
|
| max value on treatment (N=43, 75) |
63
(89)
|
62
(50)
|
| last value on treatment (N=43, 75) |
40
(23)
|
49
(39)
|
| Title | Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total] |
|---|---|
| Description | This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure Bilirubin total is presented. |
| Time Frame | baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Relapse | Non-relapse |
|---|---|---|
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. |
| Measure Participants | 43 | 75 |
| Baseline (N=43, 75) |
0.5
(0.2)
|
0.5
(0.2)
|
| week 4 (N=43, 74) |
2.8
(1.6)
|
2.6
(1.7)
|
| week 12 (N=43, 67) |
2.7
(1.8)
|
2.7
(1.9)
|
| min value on treatment (N=43, 75) |
1.9
(1.3)
|
1.9
(1.5)
|
| max value on treatment (N=43, 75) |
3.6
(2.1)
|
3.5
(2.2)
|
| last value on treatment (N=43, 75) |
2.6
(1.8)
|
2.6
(1.9)
|
Adverse Events
| Time Frame | from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Relapse | Non-relapse | ||
| Arm/Group Description | FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV. | FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV. | ||
All Cause Mortality |
||||
| Relapse | Non-relapse | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Relapse | Non-relapse | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/43 (2.3%) | 6/75 (8%) | ||
| Gastrointestinal disorders | ||||
| Ascites | 0/43 (0%) | 1/75 (1.3%) | ||
| Diarrhoea | 0/43 (0%) | 1/75 (1.3%) | ||
| Mallory-Weiss syndrome | 1/43 (2.3%) | 0/75 (0%) | ||
| Hepatobiliary disorders | ||||
| Hepatic failure | 1/43 (2.3%) | 0/75 (0%) | ||
| Infections and infestations | ||||
| Gastroenteritis | 0/43 (0%) | 1/75 (1.3%) | ||
| Oral fungal infection | 0/43 (0%) | 1/75 (1.3%) | ||
| Pneumonia | 1/43 (2.3%) | 0/75 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 0/43 (0%) | 1/75 (1.3%) | ||
| Dehydration | 0/43 (0%) | 1/75 (1.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal chest pain | 0/43 (0%) | 1/75 (1.3%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer | 0/43 (0%) | 1/75 (1.3%) | ||
| Nervous system disorders | ||||
| Presyncope | 0/43 (0%) | 1/75 (1.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Relapse | Non-relapse | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/43 (88.4%) | 68/75 (90.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 9/43 (20.9%) | 20/75 (26.7%) | ||
| Neutropenia | 2/43 (4.7%) | 7/75 (9.3%) | ||
| Thrombocytopenia | 1/43 (2.3%) | 5/75 (6.7%) | ||
| Eye disorders | ||||
| Dry eye | 1/43 (2.3%) | 4/75 (5.3%) | ||
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 0/43 (0%) | 4/75 (5.3%) | ||
| Abdominal pain | 6/43 (14%) | 3/75 (4%) | ||
| Abdominal pain upper | 2/43 (4.7%) | 8/75 (10.7%) | ||
| Diarrhoea | 14/43 (32.6%) | 21/75 (28%) | ||
| Dry mouth | 0/43 (0%) | 4/75 (5.3%) | ||
| Dyspepsia | 2/43 (4.7%) | 5/75 (6.7%) | ||
| Nausea | 22/43 (51.2%) | 34/75 (45.3%) | ||
| Stomatitis | 3/43 (7%) | 2/75 (2.7%) | ||
| Vomiting | 11/43 (25.6%) | 15/75 (20%) | ||
| General disorders | ||||
| Asthenia | 7/43 (16.3%) | 13/75 (17.3%) | ||
| Chills | 3/43 (7%) | 2/75 (2.7%) | ||
| Fatigue | 14/43 (32.6%) | 11/75 (14.7%) | ||
| Influenza like illness | 5/43 (11.6%) | 4/75 (5.3%) | ||
| Malaise | 1/43 (2.3%) | 6/75 (8%) | ||
| Pyrexia | 4/43 (9.3%) | 8/75 (10.7%) | ||
| Hepatobiliary disorders | ||||
| Hyperbilirubinaemia | 12/43 (27.9%) | 6/75 (8%) | ||
| Jaundice | 5/43 (11.6%) | 10/75 (13.3%) | ||
| Infections and infestations | ||||
| Urinary tract infection | 3/43 (7%) | 1/75 (1.3%) | ||
| Investigations | ||||
| Haemoglobin decreased | 3/43 (7%) | 1/75 (1.3%) | ||
| Weight decreased | 3/43 (7%) | 3/75 (4%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 3/43 (7%) | 16/75 (21.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 2/43 (4.7%) | 4/75 (5.3%) | ||
| Back pain | 0/43 (0%) | 4/75 (5.3%) | ||
| Muscle spasms | 2/43 (4.7%) | 4/75 (5.3%) | ||
| Myalgia | 3/43 (7%) | 9/75 (12%) | ||
| Nervous system disorders | ||||
| Dizziness | 3/43 (7%) | 5/75 (6.7%) | ||
| Dysgeusia | 2/43 (4.7%) | 4/75 (5.3%) | ||
| Headache | 10/43 (23.3%) | 15/75 (20%) | ||
| Psychiatric disorders | ||||
| Depression | 3/43 (7%) | 4/75 (5.3%) | ||
| Insomnia | 5/43 (11.6%) | 14/75 (18.7%) | ||
| Irritability | 2/43 (4.7%) | 6/75 (8%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 5/43 (11.6%) | 11/75 (14.7%) | ||
| Dyspnoea | 4/43 (9.3%) | 3/75 (4%) | ||
| Oropharyngeal pain | 2/43 (4.7%) | 4/75 (5.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 4/43 (9.3%) | 6/75 (8%) | ||
| Dry skin | 4/43 (9.3%) | 8/75 (10.7%) | ||
| Eczema | 1/43 (2.3%) | 5/75 (6.7%) | ||
| Photosensitivity reaction | 3/43 (7%) | 1/75 (1.3%) | ||
| Pruritus | 13/43 (30.2%) | 23/75 (30.7%) | ||
| Rash | 12/43 (27.9%) | 21/75 (28%) | ||
| Vascular disorders | ||||
| Hypertension | 3/43 (7%) | 1/75 (1.3%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
- 1220.48
- 2011-000141-20