The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01425203
Collaborator
(none)
238
3
22.9

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

Study Type:
Interventional
Actual Enrollment :
238 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Ribavirin
Actual Study Start Date :
Nov 23, 2011
Actual Primary Completion Date :
Oct 21, 2013
Actual Study Completion Date :
Oct 21, 2013

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:
  • SCH 503034
  • Biological: peginterferon alfa-2b
    peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
    Other Names:
  • PegIntron
  • 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:
  • PegIntron
  • 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:
  • SCH 503034
  • Biological: peginterferon alfa-2b
    peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
    Other Names:
  • PegIntron
  • Drug: Ribavirin
    ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01425203
    Other Study ID Numbers:
    • P08160
    • MK-3034-046
    First Posted:
    Aug 29, 2011
    Last Update Posted:
    Feb 8, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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.
    2. Secondary Outcome
    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.
    3. Secondary Outcome
    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

    [Not Specified]

    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
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01425203
    Other Study ID Numbers:
    • P08160
    • MK-3034-046
    First Posted:
    Aug 29, 2011
    Last Update Posted:
    Feb 8, 2021
    Last Verified:
    Jan 1, 2021