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)

Hepatitis C, Chronic Clinical Trial

— START 4  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01606800
• Other study ID #: 8908B-059
• Secondary ID: MK-8908B-059
• Status: Terminated
• Phase: Phase 4
• Start date: January 1, 2013
• Est. completion date: January 26, 2015

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: January 26, 2015
• Est. primary completion date: January 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• PEG-IFN alfa-2b
Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
• ribavirin
Ribavirin 200 mg capsules administered orally daily based on weight

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Achieving Sustained Virologic Response (SVR)	SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.	At 24 weeks after the completion of therapy (up to 72 weeks)