Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)
PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study
1 other identifier
interventional
357
0 countries
N/A
Brief Summary
The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedResults Posted
Study results publicly available
December 29, 2011
CompletedOctober 14, 2015
October 1, 2015
1.8 years
September 8, 2005
May 13, 2011
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)
Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
Baseline up to Week 49
Percent of Participants Who Achieved Sustained Virologic Response (SVR)
SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
Baseline up to Week 73 [24 weeks after end of treatment (EoT)]
Secondary Outcomes (10)
Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA
Baseline up to Week 73 [24 weeks after EoT]
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
Week 1 and Week 49
Percent of Participants With Virologic Response Prior to Amendment 2
Week 3, Week 5, Week 13
Peak Plasma Concentration of Boceprevir (BOC)
All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period
All visits during treatment (baseline to Week 49) except Day 1 of Week 1
- +5 more secondary outcomes
Study Arms (9)
Arm 1A: PegIntron (PEG) + Ribavirin (RBV)
ACTIVE COMPARATORA single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is undetected, PEG + RBV will continue for another 36 weeks.
Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400
ACTIVE COMPARATORA single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is detectable, BOC 400 mg TID will be added for 36 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks)
EXPERIMENTALA single dose of PEG is given first, followed 1 week later by PEB + BOC 100 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks)
EXPERIMENTALA single dose of PEG is given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 4: PegIntron (PEG) + Boceprevir (BOC) 400 (48 weeks)
EXPERIMENTALA single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400
EXPERIMENTALA single dose of PEG is given first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 6: PegIntron (PEG) + Boceprevir (BOC) 400 (24 Weeks)
EXPERIMENTALA single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 7: PegIntron (PEG) + Boceprevir (BOC) 800
EXPERIMENTALBy first protocol amendment to P03659, this non-randomized arm is added. A single dose of PEG is given first, followed 1 week later by PEG + BOC 800 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800
EXPERIMENTALBy second protocol amendment to P03659, participants from all arms except Arm 1A will be rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
Interventions
100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID
1.5 mcg/kg weekly subcutaneously
200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])
Eligibility Criteria
You may qualify if:
- Documented infection with chronic hepatitis C (CHC), genotype 1.
- Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as \<2 log drop in HCV-RNA after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid (HCV)-RNA negative)
- No evidence of cirrhosis on liver biopsy.
- Results of physical examination and laboratory tests within specified ranges.
- Abstinence from use of abused substances.
You may not qualify if:
- Women who are pregnant or nursing a child.
- Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency virus (HIV), and African-American patients (by protocol amendment 2, African-American patients can enroll).
- Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor.
- Patients who relapsed following response to previous treatment.
- Evidence of advanced liver disease, or liver disease from a cause other than CHC.
- Pre-existing psychiatric condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The implementation of amendment 2 led to changes in boceprevir dose in all treatment arms and different overall lengths of therapy within the same treatment arm, making the SVR endpoint uninterpretable.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
September 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
October 14, 2015
Results First Posted
December 29, 2011
Record last verified: 2015-10