Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT00160251
Start Date
September 1 2005
End Date
July 1 2007
Last Update
October 14 2015
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