A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039)

NCT ID: NCT01716156

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-18
• Study Completion Date: 2014-03-12

Brief Summary

This study will compare two different durations of treatment with grazoprevir (MK-5172) in combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination therapy.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Grazoprevir 100 mg + RBV 12 Weeks

Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.

Group Type: EXPERIMENTAL

Grazoprevir

Intervention Type: DRUG

Grazoprevir, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment

Ribavirin

Intervention Type: DRUG

Ribavirin capsules, orally, twice per day, at a total daily dose from 800 to 1400 mg based on participant weight

Grazoprevir 100 mg + RBV 24 Weeks

Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.

Group Type: EXPERIMENTAL

Grazoprevir

Intervention Type: DRUG

Grazoprevir, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment

Ribavirin

Intervention Type: DRUG

Ribavirin capsules, orally, twice per day, at a total daily dose from 800 to 1400 mg based on participant weight

Interventions

Grazoprevir

Grazoprevir, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment

Intervention Type: DRUG

Ribavirin

Ribavirin capsules, orally, twice per day, at a total daily dose from 800 to 1400 mg based on participant weight

Intervention Type: DRUG

Other Intervention Names

Rebetol™; RBV

Eligibility Criteria

Inclusion Criteria

• Chronic, compensated HCV GT 1 hepatitis C
• IL28B CC genotype
• Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis
• No evidence of cirrhosis and hepatocellular carcinoma by biopsy or noninvasive tests (FibroScan and/or FibroTest)
• Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential)

Exclusion Criteria

• Non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype
• Previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV
• Human immunodeficiency virus (HIV) positive or known to be co-infected with hepatitis B virus
• Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC
• Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study
• Diabetes and/or hypertension with clinically significant ocular examination findings
• Current moderate or severe depression or history of depression associated with hospitalization, electroconvulsive therapy, or severe disruption of daily functions, or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric disorders
• Clinical diagnosis of substance abuse
• Current or history of seizure disorder, stroke, or transient ischemic attack
• Immunologically-mediated disease
• Chronic pulmonary disease
• Clinically significant cardiac abnormalities/dysfunction
• Active clinical gout within the last year
• Hemoglobinopathy or myelodysplastic syndromes
• History of organ transplants
• Poor venous access
• Indwelling venous catheter
• History of gastric surgery or malabsorption disorder
• Severe concurrent disease
• Evidence of active or suspected malignancy, or under evaluation for malignancy, or history of malignancy, within the last 5 years
• Pregnant, lactating, or expecting to conceive or donate eggs
• Male participant whose female partner is pregnant
• Member or a family member of the investigational study staff or sponsor staff directly involved with this study
• History of chronic hepatitis not caused by HCV

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Gane E, Ben Ari Z, Mollison L, Zuckerman E, Bruck R, Baruch Y, Howe AY, Wahl J, Bhanja S, Hwang P, Zhao Y, Robertson MN. Efficacy and safety of grazoprevir + ribavirin for 12 or 24 weeks in treatment-naive patients with hepatitis C virus genotype 1 infection. J Viral Hepat. 2016 Oct;23(10):789-97. doi: 10.1111/jvh.12552. Epub 2016 Jun 12.

Reference Type: RESULT

PMID: 27291249 (View on PubMed)

Other Identifiers

2012-003340-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

5172-039

Identifier Type: -

Identifier Source: org_study_id