The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: RGT BOC + PR Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. |
Drug: Boceprevir
boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
Other Names:
Biological: peginterferon alfa-2b
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
Other Names:
Drug: Ribavirin
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
|
Placebo Comparator: PBO + PR (Control) Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. |
Drug: Placebo
boceprevir-matched placebo four 200-mg capsules PO TID.
Biological: peginterferon alfa-2b
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
Other Names:
Drug: Ribavirin
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
|
Experimental: Crossover Arm Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR. |
Drug: Boceprevir
boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
Other Names:
Biological: peginterferon alfa-2b
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
Other Names:
Drug: Ribavirin
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population) [Follow-up Week 24 (up to 72 weeks)]
SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.
Secondary Outcome Measures
- Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population) [Follow-up Week 24 (up to 72 weeks)]
SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.
- Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8 [Treatment Week 8]
EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.
Eligibility Criteria
Criteria
Inclusion criteria:
-
body weight ≥40 kg and ≤125 kg
-
previously documented CHC genotype 1 infection;
-
must have a liver biopsy with histology consistent with CHC and no other etiology
-
if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)
-
agree to use acceptable methods of contraception with partner
-
previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV
Exclusion criteria:
-
co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] positive).
-
required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related)
-
treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening
-
treatment with any investigational drug within 30 days of the screening visit in this trial
-
evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
-
diabetic and/or hypertensive with clinically significant ocular examination findings
-
clinical diagnosis of substance abuse of specified drugs within specified timeframes
-
any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P08160
- MK-3034-046
Study Results
Participant Flow
Recruitment Details | A total of 18 Russian sites recruited participants for this boceprevir (BOC) trial. |
---|---|
Pre-assignment Detail | Of 238 randomized participants, 237 received at least 1 dose of peginterferon alpha-2b (PEG) + ribavirin (RBV) [PR] and comprised the Full Analysis Set (FAS). 4 discontinued (DC) treatment during the PR lead-in phase and did not receive BOC or Placebo (PBO). 27 from PBO Arm failed the futility time point and were rolled over into Crossover Phase. |
Arm/Group Title | RGT BOC + PR | PBO + PR (Control) | Crossover Arm |
---|---|---|---|
Arm/Group Description | Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. | Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. | Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8. |
Period Title: Treatment Phase | |||
STARTED | 159 | 79 | 0 |
Treated (FAS) | 159 | 78 | 0 |
COMPLETED | 132 | 42 | 0 |
NOT COMPLETED | 27 | 37 | 0 |
Period Title: Treatment Phase | |||
STARTED | 0 | 0 | 27 |
COMPLETED | 0 | 0 | 21 |
NOT COMPLETED | 0 | 0 | 6 |
Period Title: Treatment Phase | |||
STARTED | 153 | 49 | 27 |
COMPLETED | 153 | 49 | 27 |
NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | RGT BOC + PR | PBO + PR (Control) | Total |
---|---|---|---|
Arm/Group Description | Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. | Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. | Total of all reporting groups |
Overall Participants | 159 | 78 | 237 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
38.6
(9.8)
|
38.1
(10.0)
|
38.4
(9.8)
|
Sex: Female, Male (Count of Participants) | |||
Female |
65
40.9%
|
33
42.3%
|
98
41.4%
|
Male |
94
59.1%
|
45
57.7%
|
139
58.6%
|
Outcome Measures
Title | Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population) |
---|---|
Description | SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder. |
Time Frame | Follow-up Week 24 (up to 72 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here. |
Arm/Group Title | RGT BOC + PR | PBO + PR (Control) | Crossover Arm |
---|---|---|---|
Arm/Group Description | Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. | Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. | Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8. |
Measure Participants | 159 | 78 | 0 |
Number [percentage of participants] |
74.8
47%
|
46.2
59.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | RGT BOC + PR, PBO + PR (Control) |
---|---|---|
Comments | The primary statistical comparison was conducted on the FAS using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors, including IL28B genotype and previous treatment as specified at the time of randomization. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | Multiplicity adjustment for controlling type 1 error for the primary comparison was based on the step-down approach. | |
Method | Miettinen and Nurminen Method | |
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted Difference in Percentages |
Estimated Value | 29.2 | |
Confidence Interval |
(2-Sided) 95% 16.4 to 41.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen & Nurminen method. |
Title | Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population) |
---|---|
Description | SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder. |
Time Frame | Follow-up Week 24 (up to 72 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
mITT population included all randomized participants who received ≥1 dose of experimental trial drug: BOC (for Experimental RGT BOC + PR arm) or Placebo (for PBO + PR Control arm). Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here. |
Arm/Group Title | RGT BOC + PR | PBO + PR (Control) | Crossover Arm |
---|---|---|---|
Arm/Group Description | Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. | Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. | Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8. |
Measure Participants | 156 | 77 | 0 |
Number [percentage of participants] |
76.3
48%
|
46.8
60%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | RGT BOC + PR, PBO + PR (Control) |
---|---|---|
Comments | The key secondary statistical comparison was conducted on the mITT using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | Multiplicity adjustment for controlling type 1 error for key secondary comparison based on a step-down approach. Key-secondary comparison was tested only if statistical significance of primary comparison was met at alpha level of 0.050. | |
Method | Miettinen and Nurminen Method | |
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted Difference in Percentages |
Estimated Value | 30.2 | |
Confidence Interval |
(2-Sided) 95% 17.3 to 42.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen & Nurminen method. |
Title | Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8 |
---|---|
Description | EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8. |
Time Frame | Treatment Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. The Crossover arm had zero participants at TW8 since the first opportunity for participants in the PBO + PR Control arm to roll over to the Crossover arm was at TW12. |
Arm/Group Title | RGT BOC + PR | PBO + PR (Control) | Crossover Arm |
---|---|---|---|
Arm/Group Description | Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. | Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. | Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8. |
Measure Participants | 159 | 78 | 0 |
Number [percentage of participants] |
87.4
55%
|
42.3
54.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | RGT BOC + PR, PBO + PR (Control) |
---|---|---|
Comments | The percentage of participants achieving EVR at TW8 was compared using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors in the FAS population. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Miettinen and Nurminen Method | |
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted Difference in Percentages |
Estimated Value | 45.6 | |
Confidence Interval |
(2-Sided) 95% 33.2 to 57.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen & Nurminen method. |
Adverse Events
Time Frame | RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately. | |||||
Arm/Group Title | RGT BOC + PR | PBO + PR (Control) | Crossover Arm | |||
Arm/Group Description | Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. | Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. | Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8. | |||
All Cause Mortality |
||||||
RGT BOC + PR | PBO + PR (Control) | Crossover Arm | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
RGT BOC + PR | PBO + PR (Control) | Crossover Arm | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 17/159 (10.7%) | 9/78 (11.5%) | 1/27 (3.7%) | |||
Blood and lymphatic system disorders | ||||||
Neutropenia | 11/159 (6.9%) | 14 | 4/78 (5.1%) | 4 | 1/27 (3.7%) | 1 |
Gastrointestinal disorders | ||||||
Intestinal obstruction | 1/159 (0.6%) | 1 | 0/78 (0%) | 0 | 0/27 (0%) | 0 |
General disorders | ||||||
Adverse event | 0/159 (0%) | 0 | 1/78 (1.3%) | 1 | 0/27 (0%) | 0 |
Infections and infestations | ||||||
Osteomyelitis chronic | 1/159 (0.6%) | 1 | 0/78 (0%) | 0 | 0/27 (0%) | 0 |
Pneumonia | 1/159 (0.6%) | 1 | 0/78 (0%) | 0 | 0/27 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||
Accidental overdose | 0/159 (0%) | 0 | 1/78 (1.3%) | 1 | 0/27 (0%) | 0 |
Metabolism and nutrition disorders | ||||||
Diabetic ketoacidosis | 1/159 (0.6%) | 1 | 0/78 (0%) | 0 | 0/27 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||
Intervertebral disc protrusion | 1/159 (0.6%) | 1 | 0/78 (0%) | 0 | 0/27 (0%) | 0 |
Nervous system disorders | ||||||
Transient ischaemic attack | 1/159 (0.6%) | 1 | 0/78 (0%) | 0 | 0/27 (0%) | 0 |
Reproductive system and breast disorders | ||||||
Prostatitis | 0/159 (0%) | 0 | 1/78 (1.3%) | 1 | 0/27 (0%) | 0 |
Vascular disorders | ||||||
Hypertension | 0/159 (0%) | 0 | 2/78 (2.6%) | 2 | 0/27 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
RGT BOC + PR | PBO + PR (Control) | Crossover Arm | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 153/159 (96.2%) | 71/78 (91%) | 22/27 (81.5%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 75/159 (47.2%) | 105 | 19/78 (24.4%) | 31 | 12/27 (44.4%) | 18 |
Leukopenia | 62/159 (39%) | 103 | 25/78 (32.1%) | 35 | 6/27 (22.2%) | 8 |
Neutropenia | 80/159 (50.3%) | 141 | 29/78 (37.2%) | 45 | 8/27 (29.6%) | 15 |
Thrombocytopenia | 11/159 (6.9%) | 16 | 5/78 (6.4%) | 7 | 3/27 (11.1%) | 4 |
Gastrointestinal disorders | ||||||
Diarrhoea | 18/159 (11.3%) | 22 | 3/78 (3.8%) | 3 | 0/27 (0%) | 0 |
Dry mouth | 11/159 (6.9%) | 13 | 5/78 (6.4%) | 5 | 1/27 (3.7%) | 1 |
Nausea | 39/159 (24.5%) | 59 | 9/78 (11.5%) | 15 | 4/27 (14.8%) | 5 |
Vomiting | 9/159 (5.7%) | 12 | 2/78 (2.6%) | 2 | 1/27 (3.7%) | 1 |
General disorders | ||||||
Asthenia | 44/159 (27.7%) | 63 | 23/78 (29.5%) | 23 | 4/27 (14.8%) | 18 |
Chills | 16/159 (10.1%) | 24 | 2/78 (2.6%) | 2 | 0/27 (0%) | 0 |
Fatigue | 30/159 (18.9%) | 40 | 11/78 (14.1%) | 18 | 1/27 (3.7%) | 3 |
Hyperthermia | 8/159 (5%) | 51 | 4/78 (5.1%) | 12 | 0/27 (0%) | 0 |
Influenza like illness | 39/159 (24.5%) | 356 | 14/78 (17.9%) | 72 | 2/27 (7.4%) | 30 |
Injection site erythema | 9/159 (5.7%) | 9 | 2/78 (2.6%) | 2 | 0/27 (0%) | 0 |
Irritability | 17/159 (10.7%) | 18 | 9/78 (11.5%) | 11 | 1/27 (3.7%) | 2 |
Pyrexia | 77/159 (48.4%) | 271 | 36/78 (46.2%) | 124 | 1/27 (3.7%) | 2 |
Investigations | ||||||
Body temperature increased | 8/159 (5%) | 14 | 2/78 (2.6%) | 2 | 1/27 (3.7%) | 3 |
Weight decreased | 28/159 (17.6%) | 33 | 9/78 (11.5%) | 9 | 3/27 (11.1%) | 3 |
Metabolism and nutrition disorders | ||||||
Decreased appetite | 10/159 (6.3%) | 10 | 5/78 (6.4%) | 7 | 2/27 (7.4%) | 2 |
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 14/159 (8.8%) | 16 | 4/78 (5.1%) | 4 | 0/27 (0%) | 0 |
Myalgia | 15/159 (9.4%) | 33 | 7/78 (9%) | 8 | 0/27 (0%) | 0 |
Nervous system disorders | ||||||
Dizziness | 9/159 (5.7%) | 9 | 7/78 (9%) | 7 | 0/27 (0%) | 0 |
Dysgeusia | 59/159 (37.1%) | 69 | 3/78 (3.8%) | 5 | 15/27 (55.6%) | 18 |
Headache | 43/159 (27%) | 89 | 25/78 (32.1%) | 51 | 5/27 (18.5%) | 13 |
Psychiatric disorders | ||||||
Sleep disorder | 2/159 (1.3%) | 2 | 4/78 (5.1%) | 4 | 0/27 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 25/159 (15.7%) | 38 | 12/78 (15.4%) | 14 | 1/27 (3.7%) | 1 |
Dyspnoea | 7/159 (4.4%) | 7 | 6/78 (7.7%) | 7 | 0/27 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||
Alopecia | 32/159 (20.1%) | 33 | 16/78 (20.5%) | 16 | 1/27 (3.7%) | 1 |
Dry skin | 12/159 (7.5%) | 12 | 3/78 (3.8%) | 3 | 0/27 (0%) | 0 |
Pruritus | 19/159 (11.9%) | 20 | 5/78 (6.4%) | 6 | 0/27 (0%) | 0 |
Rash | 10/159 (6.3%) | 17 | 2/78 (2.6%) | 2 | 1/27 (3.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Investigator agrees not to publish or publicly present any interim results of trial without prior written consent of Sponsor. Investigator further agrees to provide to Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. Sponsor has right to review and comment with respect to publications, abstracts, slides, data analysis and presentation
Results Point of Contact
Name/Title | Vice President, Late Stage Development Group Leader |
---|---|
Organization | Merck Sharp & Dohme Corp. |
Phone | 1-800-672-6372 |
ClinicalTrialsDisclosure@merck.com |
- P08160
- MK-3034-046