Status:
TERMINATED
Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatmen...
Eligibility Criteria
Inclusion
- Body weight ≥ 88 lbs and ≤ 275 lbs
- Documented chronic Hepatitis C (CHC) GT2 or GT3 infection
- No known cirrhosis
- Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
- Chest X-ray within the last 6 months
- Eye exam within the last 6 months
Exclusion
- Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen)
- Prior approved or investigational treatment for hepatitis C
- Evidence of hepatocellular carcinoma
- Diabetic and/or high blood pressure with clinically significant eye exam findings
- Pre-existing psychiatric condition
- Clinical diagnosis of abuse of certain substances within specified timeframes
- Known medical condition that could interfere with participation
- Active or suspected cancer within the last 5 years
- Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs
- Male who is planning to impregnate partner or donate sperm
- Male with a pregnant female partner
- Chronic hepatitis not caused by HCV
Key Trial Info
Start Date :
November 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01440595
Start Date
November 28 2011
End Date
May 1 2012
Last Update
May 22 2024
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