Clinical trial NCT00160251: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: PEG-Intron
Ribavirin
Protease Inhibitor
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key inclusion criteria:

* 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.

Key exclusion criteria:

* 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.

Primary outcomes:
measure: Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)
timeFrame: Baseline up to Week 49
measure: Percent of Participants Who Achieved Sustained Virologic Response (SVR)
timeFrame: Baseline up to Week 73 [24 weeks after end of treatment (EoT)]
Secondary outcomes:
measure: Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA
timeFrame: Baseline up to Week 73 [24 weeks after EoT]
measure: Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
timeFrame: Week 1 and Week 49
measure: Percent of Participants With Virologic Response Prior to Amendment 2
timeFrame: Week 3, Week 5, Week 13
measure: Peak Plasma Concentration of Boceprevir (BOC)
timeFrame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
measure: Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period
timeFrame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
measure: Trough Plasma Concentration Level
timeFrame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
measure: Change in Alanine Aminotransferase (ALT) Levels
timeFrame: Baseline up to dosing change (> 25 weeks)
measure: Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
timeFrame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)
measure: Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
timeFrame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)
measure: Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
timeFrame: From dosing change to end of follow-up (Week 73) (up to 48 weeks)
Other outcomes:
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