Clinical trial NCT01440595: Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
Official title: A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-09-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms
timeFrame: Week 12
Secondary outcomes:
measure: Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)
timeFrame: Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm
measure: Number of Participants Achieving Rapid Viral Response (RVR)
timeFrame: Week 4
measure: Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)
timeFrame: Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm
measure: Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)
timeFrame: Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm
measure: Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm
timeFrame: Week 12
measure: Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm
timeFrame: Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: