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Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: PEG-IFN alfa-2b (Drug); ribavirin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Merck Sharp & Dohme Corp.

Summary

The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.

Clinical Details

Official title: Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants Achieving Sustained Virologic Response (SVR)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participant is ≥40 kg and ≤120 kg weight

- Participant and participant's partner(s) must each agree to use acceptable methods of

contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.

- Previously documented CHC genotype 4 infection

- Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no

other etiology and with hepatic fibrosis scores (F0, F1, F2, F3). Exclusion Criteria:

- Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus

- Treatment for hepatitis C with any investigational medication

- Treatment with any investigational drug within 30 days of the screening visit

- Evidence of decompensated liver disease including, but not limited to, a history or

presence of clinical ascites, bleeding varices, or hepatic encephalopathy

- Autoimmune hepatitis or a history of autoimmune disease

- Hepatic fibrosis score F4

- Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac

disease in the previous six months

- Autoimmune hepatitis or a history of autoimmune disease

- Thyroid disease uncontrolled with conventional treatment

- Epilepsy and/or compromised central nervous system (CNS) function

Locations and Contacts

Additional Information

Starting date: January 2013
Last updated: June 23, 2015

Page last updated: August 23, 2015

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