Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)

• Status: Withdrawn
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Weight ≥ 40 kg to ≤ 125 kg

• Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception

• Must have documented Chronic Hepatitis C Genotype 1 infection

• Must have failed prior treatment with interferon plus ribavirin

• Must have completed treatment with interferon plus ribavirin for at least 12 weeks

• Must have had a liver biopsy or Fibroscan to determine status as cirrhotic or non-cirrhotic

• Participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the Screening visit

Exclusion Criteria:

• Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus

• Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment

• Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit

• Treatment with any investigational drug within 30 days prior to the Screening visit

• Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit

• Participation in any investigational trial within 30 days of the Screening visit

• Evidence of decompensated liver disease

• Child Pugh score > 6 (Class B and C)

• Diabetic and/or hypertensive participants with clinically significant ocular examination findings

• Pre-existing psychiatric conditions

• Clinical diagnosis of substance abuse

• Active or suspected malignancy

• Pregnant or nursing