Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01440595
• Other study ID #: 5172-012
• Secondary ID: 2011-003299-36
• Status: Terminated
• Phase: Phase 2
• Start date: November 28, 2011
• Est. completion date: May 1, 2012

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 1, 2012
• Est. primary completion date: May 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Grazoprevir
Grazoprevir 100 mg tablets once daily for 12 weeks.
• Placebo to Grazoprevir
Placebo to Grazoprevir once daily for 12 weeks
• Peginterferon alfa-2b (Peg-IFN)
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
• Ribavirin (RBV)
Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms	cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.	Week 12
Secondary	Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)	Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.	Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm
Secondary	Number of Participants Achieving Rapid Viral Response (RVR)	RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.	Week 4
Secondary	Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)	SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.	Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm
Secondary	Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)	SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.	Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm
Secondary	Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm	HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.	Week 12
Secondary	Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm	cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.	Week 24