Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01017575
Collaborator
(none)
55
6
5
22
9.2
0.4
Study Details
Study Description
Brief Summary
The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Study Start Date
:
Dec 1, 2009
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Oct 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin) Treatment Naive |
Drug: Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
|
| Experimental: Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin) Treatment Naive |
Drug: Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
|
| Placebo Comparator: Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin) Treatment Naive |
Drug: Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
|
| Experimental: Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin) Non-Responder |
Drug: Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
|
| Experimental: Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin) Non-Responder |
Drug: Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Names:
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Extended Rapid Virologic Response (eRVR) [From Week 4 up to Week 12]
eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12.
Secondary Outcome Measures
- Percentage of Participants With Rapid Virologic Response (RVR) [Week 4]
RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.
- Percentage of Participants With a Complete Early Virologic Response (cEVR) [Week 12]
cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.
- Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 [Follow up Week 12, Follow up Week 24]
SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24.
Other Outcome Measures
- Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. [From Baseline up to 30 days after last dose of study drug]
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
- Number of Participants With Grade 3 to 4 Laboratory Abnormalities [From screening up to Week 12 (treatment period)]
Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Subjects chronically infected with hepatitis C virus (HCV) genotype 1
-
HCV RNA viral load ≥ 105 IU/mL (100,000 IU/mL) at screening
-
The current standard of care naïve or non-responder
Key Exclusion Criteria:
-
Cirrhosis
-
HCC
-
Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Chiba-Shi | Chiba | Japan | |
| 2 | Local Institution | Kurume-Shi | Fukuoka | Japan | 8300011 |
| 3 | Local Institution | Okayama-Shi | Okayama | Japan | 7008558 |
| 4 | Local Institution | Osaka-Shi | Osaka | Japan | 5438555 |
| 5 | Local Institution | Osaka-Shi | Osaka | Japan | 545-8586 |
| 6 | Local Institution | Musashino-Shi | Tokyo | Japan | 180-0023 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01017575
Other Study ID Numbers:
- AI444-022
First Posted:
Nov 20, 2009
Last Update Posted:
Sep 11, 2015
Last Verified:
Aug 1, 2015
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 6 sites in Japan. |
|---|---|
| Pre-assignment Detail | A total of 55 participants were enrolled, of which 43 participants were randomized and 42 were treated. 12 participants were not randomized because 10 no longer met study criteria and 2 withdrew consent; 1 randomized participant was not treated due enlarged lymph node. |
| Arm/Group Title | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| Period Title: Overall Study | |||||
| STARTED | 8 | 9 | 8 | 8 | 9 |
| COMPLETED | 7 | 7 | 8 | 7 | 6 |
| NOT COMPLETED | 1 | 2 | 0 | 1 | 3 |
Baseline Characteristics
| Arm/Group Title | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Total of all reporting groups |
| Overall Participants | 8 | 9 | 8 | 8 | 9 | 42 |
| Age, Customized (participants) [Number] | ||||||
| <65 years |
7
87.5%
|
8
88.9%
|
6
75%
|
6
75%
|
8
88.9%
|
35
83.3%
|
| >=65 years |
1
12.5%
|
1
11.1%
|
2
25%
|
2
25%
|
1
11.1%
|
7
16.7%
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
5
62.5%
|
5
55.6%
|
6
75%
|
2
25%
|
4
44.4%
|
22
52.4%
|
| Male |
3
37.5%
|
4
44.4%
|
2
25%
|
6
75%
|
5
55.6%
|
20
47.6%
|
Outcome Measures
| Title | Percentage of Participants With Rapid Virologic Response (RVR) |
|---|---|
| Description | RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4. |
| Time Frame | Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of study therapy. |
| Arm/Group Title | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| Measure Participants | 8 | 9 | 8 | 8 | 9 |
| Number [percentage of participants] |
12.5
156.3%
|
77.8
864.4%
|
62.5
781.3%
|
62.5
781.3%
|
88.9
987.8%
|
| Title | Percentage of Participants With a Complete Early Virologic Response (cEVR) |
|---|---|
| Description | cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of study therapy. |
| Arm/Group Title | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| Measure Participants | 8 | 9 | 8 | 8 | 9 |
| Number [percentage of participants] |
62.5
781.3%
|
88.9
987.8%
|
100
1250%
|
87.5
1093.8%
|
88.9
987.8%
|
| Title | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 |
|---|---|
| Description | SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24. |
| Time Frame | Follow up Week 12, Follow up Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of study therapy. |
| Arm/Group Title | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| Measure Participants | 8 | 9 | 8 | 8 | 9 |
| SVR12 |
75
937.5%
|
88.9
987.8%
|
100
1250%
|
50
625%
|
77.8
864.4%
|
| SVR24 |
75
937.5%
|
88.9
987.8%
|
100
1250%
|
50
625%
|
77.8
864.4%
|
| Title | Percentage of Participants With Extended Rapid Virologic Response (eRVR) |
|---|---|
| Description | eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12. |
| Time Frame | From Week 4 up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of study therapy. |
| Arm/Group Title | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| Measure Participants | 8 | 9 | 8 | 8 | 9 |
| Number [percentage of participants] |
12.5
156.3%
|
66.7
741.1%
|
62.5
781.3%
|
62.5
781.3%
|
77.8
864.4%
|
| Title | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. |
|---|---|
| Description | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. |
| Time Frame | From Baseline up to 30 days after last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of study therapy. |
| Arm/Group Title | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| Measure Participants | 8 | 9 | 8 | 8 | 9 |
| SAEs |
0
0%
|
2
22.2%
|
0
0%
|
0
0%
|
0
0%
|
| Discontinuations due to AEs |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
2
22.2%
|
| Death |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Grade 3 to 4 Laboratory Abnormalities |
|---|---|
| Description | Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN. |
| Time Frame | From screening up to Week 12 (treatment period) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants who received at least 1 dose of study therapy. |
| Arm/Group Title | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. |
| Measure Participants | 8 | 9 | 8 | 8 | 9 |
| Hemoglobin |
0
0%
|
2
22.2%
|
1
12.5%
|
0
0%
|
2
22.2%
|
| Lymphocytes |
5
62.5%
|
2
22.2%
|
4
50%
|
5
62.5%
|
3
33.3%
|
| Neutrophils |
4
50%
|
4
44.4%
|
3
37.5%
|
3
37.5%
|
2
22.2%
|
| Platelets |
0
0%
|
0
0%
|
0
0%
|
2
25%
|
0
0%
|
| WBC |
3
37.5%
|
1
11.1%
|
2
25%
|
2
25%
|
2
22.2%
|
| AST |
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
| Lipase |
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | |||||
| Arm/Group Description | Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | |||||
All Cause Mortality |
||||||||||
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 2/9 (22.2%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Pancreatitis acute | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Back pain | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/8 (100%) | 9/9 (100%) | 8/8 (100%) | 8/8 (100%) | 9/9 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 5/8 (62.5%) | 6/9 (66.7%) | 5/8 (62.5%) | 4/8 (50%) | 5/9 (55.6%) | |||||
| Leukopenia | 3/8 (37.5%) | 1/9 (11.1%) | 2/8 (25%) | 2/8 (25%) | 2/9 (22.2%) | |||||
| Lymphopenia | 5/8 (62.5%) | 2/9 (22.2%) | 4/8 (50%) | 5/8 (62.5%) | 3/9 (33.3%) | |||||
| Thrombocytopenia | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 3/8 (37.5%) | 0/9 (0%) | |||||
| Neutropenia | 4/8 (50%) | 4/9 (44.4%) | 3/8 (37.5%) | 3/8 (37.5%) | 2/9 (22.2%) | |||||
| Cardiac disorders | ||||||||||
| Ventricular extrasystoles | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Atrial fibrillation | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Ear discomfort | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Vertigo positional | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Vertigo | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Endocrine disorders | ||||||||||
| Hyperthyroidism | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Eye disorders | ||||||||||
| Retinopathy | 1/8 (12.5%) | 2/9 (22.2%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Dry eye | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Eyelids pruritus | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Retinal haemorrhage | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Eyelid oedema | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Ocular hyperaemia | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Vitreous floaters | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Conjunctival hyperaemia | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Retinal exudates | 2/8 (25%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal discomfort | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Diarrhoea | 3/8 (37.5%) | 1/9 (11.1%) | 1/8 (12.5%) | 1/8 (12.5%) | 3/9 (33.3%) | |||||
| Gastrooesophageal reflux disease | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Gastrointestinal disorder | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Stomatitis | 2/8 (25%) | 1/9 (11.1%) | 1/8 (12.5%) | 1/8 (12.5%) | 1/9 (11.1%) | |||||
| Constipation | 0/8 (0%) | 2/9 (22.2%) | 2/8 (25%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Food poisoning | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Abdominal pain lower | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Gingival swelling | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Tongue disorder | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Abdominal pain upper | 2/8 (25%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Aphthous stomatitis | 0/8 (0%) | 1/9 (11.1%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Dry mouth | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Tooth loss | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Cheilitis | 3/8 (37.5%) | 2/9 (22.2%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Haemorrhoids | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Dental caries | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 2/9 (22.2%) | |||||
| Dyspepsia | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Nausea | 2/8 (25%) | 2/9 (22.2%) | 2/8 (25%) | 2/8 (25%) | 2/9 (22.2%) | |||||
| Pancreatitis acute | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Vomiting | 3/8 (37.5%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| General disorders | ||||||||||
| Influenza like illness | 2/8 (25%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Injection site haemorrhage | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Injection site haematoma | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Injection site reaction | 1/8 (12.5%) | 4/9 (44.4%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Irritability | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Thirst | 0/8 (0%) | 0/9 (0%) | 2/8 (25%) | 0/8 (0%) | 0/9 (0%) | |||||
| Fatigue | 4/8 (50%) | 4/9 (44.4%) | 2/8 (25%) | 3/8 (37.5%) | 2/9 (22.2%) | |||||
| Feeling abnormal | 0/8 (0%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Injection site erythema | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 1/8 (12.5%) | 1/9 (11.1%) | |||||
| Pyrexia | 5/8 (62.5%) | 6/9 (66.7%) | 5/8 (62.5%) | 6/8 (75%) | 8/9 (88.9%) | |||||
| Chills | 4/8 (50%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Malaise | 5/8 (62.5%) | 1/9 (11.1%) | 4/8 (50%) | 2/8 (25%) | 5/9 (55.6%) | |||||
| Chest discomfort | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Temperature intolerance | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Administration site reaction | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Chest pain | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Injection site pruritus | 1/8 (12.5%) | 2/9 (22.2%) | 0/8 (0%) | 0/8 (0%) | 2/9 (22.2%) | |||||
| Infections and infestations | ||||||||||
| Cystitis | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Hordeolum | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Gastroenteritis | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 2/8 (25%) | 0/9 (0%) | |||||
| Onychomycosis | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Otitis externa | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Rhinitis | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Vulvovaginitis | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Oral herpes | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Pharyngitis | 2/8 (25%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Tinea pedis | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Nasopharyngitis | 3/8 (37.5%) | 1/9 (11.1%) | 3/8 (37.5%) | 1/8 (12.5%) | 1/9 (11.1%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Anal injury | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Ankle fracture | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Heat illness | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Wound | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Contusion | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Rib fracture | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Investigations | ||||||||||
| Blood glucose increased | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Gamma-glutamyltransferase increased | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Weight decreased | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Body temperature decreased | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Aspartate aminotransferase increased | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Blood bilirubin increased | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 5/8 (62.5%) | 2/9 (22.2%) | 5/8 (62.5%) | 4/8 (50%) | 4/9 (44.4%) | |||||
| Dehydration | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Muscle rigidity | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Muscular weakness | 2/8 (25%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Musculoskeletal pain | 2/8 (25%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Myalgia | 2/8 (25%) | 1/9 (11.1%) | 0/8 (0%) | 2/8 (25%) | 1/9 (11.1%) | |||||
| Arthralgia | 2/8 (25%) | 2/9 (22.2%) | 2/8 (25%) | 2/8 (25%) | 3/9 (33.3%) | |||||
| Back pain | 2/8 (25%) | 2/9 (22.2%) | 1/8 (12.5%) | 0/8 (0%) | 4/9 (44.4%) | |||||
| Musculoskeletal stiffness | 2/8 (25%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Muscle haemorrhage | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Pain in extremity | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Nervous system disorders | ||||||||||
| Head discomfort | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Hypogeusia | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Dysgeusia | 1/8 (12.5%) | 2/9 (22.2%) | 2/8 (25%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Paraesthesia | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Visual field defect | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Headache | 4/8 (50%) | 3/9 (33.3%) | 0/8 (0%) | 4/8 (50%) | 4/9 (44.4%) | |||||
| Dizziness | 1/8 (12.5%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 2/8 (25%) | 4/9 (44.4%) | 3/8 (37.5%) | 2/8 (25%) | 3/9 (33.3%) | |||||
| Renal and urinary disorders | ||||||||||
| Pollakiuria | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Nocturia | 2/8 (25%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Menstrual disorder | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Vulvovaginal pruritus | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Choking sensation | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Dyspnoea | 0/8 (0%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Oropharyngeal pain | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Pleural effusion | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Productive cough | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Sputum retention | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Cough | 1/8 (12.5%) | 2/9 (22.2%) | 2/8 (25%) | 1/8 (12.5%) | 5/9 (55.6%) | |||||
| Dyspnoea exertional | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Epistaxis | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 1/9 (11.1%) | |||||
| Upper respiratory tract inflammation | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Oropharyngeal discomfort | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Pruritus generalised | 1/8 (12.5%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Alopecia | 6/8 (75%) | 3/9 (33.3%) | 5/8 (62.5%) | 2/8 (25%) | 3/9 (33.3%) | |||||
| Seborrhoeic dermatitis | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Dry skin | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 2/9 (22.2%) | |||||
| Rash | 3/8 (37.5%) | 5/9 (55.6%) | 2/8 (25%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Rash generalised | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
| Pruritus | 3/8 (37.5%) | 3/9 (33.3%) | 3/8 (37.5%) | 3/8 (37.5%) | 1/9 (11.1%) | |||||
| Urticaria | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Acne | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Erythema | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/9 (0%) | |||||
| Hyperkeratosis | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Eczema | 2/8 (25%) | 1/9 (11.1%) | 2/8 (25%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Rash pruritic | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/9 (0%) | |||||
| Skin exfoliation | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/9 (11.1%) | |||||
| Vascular disorders | ||||||||||
| Orthostatic hypotension | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Bristol Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title | BristolMyers Squibb Study Director |
|---|---|
| Organization | Bristol-Myers Squibb International Corporation |
| Phone | |
| clinical.trials@bms.com |
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01017575
Other Study ID Numbers:
- AI444-022
First Posted:
Nov 20, 2009
Last Update Posted:
Sep 11, 2015
Last Verified:
Aug 1, 2015