Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis Combination of Boceprevir with Ribavirin in treatment-naïve patients with genotype 4 chronic hepatitis C infection will increase the proportion of patients achieving sustained viral response compared to standard treatment alone.

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

Details

• Lead Sponsor: Theodor Bilharz Research Institute
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

• Ages Eligible for Study: 18 Years and older

• Genders Eligible for Study: Both

Inclusion Criteria:

• Subject must be more than 18 years of age.

• Subject's weight must be more than 40 kg and less than 125 kg.

• Subject and subject's partner 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.

• Subjects must be willing to give written informed consent for the trial and for the pharmacogenetic testing.

• Subjects who are unwilling to provide written informed consent for pharmacogenetic testing may be included in the trial; however, pharmacogenetic samples must not be obtained.

• Subject must have previously documented CHC genotype 4 infection.

• Subjects with other or mixed genotypes are not eligible. The HCV-RNA result obtained from the central laboratory at the screening visit must confirm genotype 4 infection and be more10,000 IU per mL Previously untreated patients with Pegylated interferon

• Subject must have a liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology.

Exclusion Criteria:

• Subject who is coinfected with the human immunodeficiency virus (HIV) or hepatitis B virus.

• Prior treatment with interferon, ribavirin and/or investigational agent for hepatitis C.

• Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.

• All herbal remedies used for hepatitis C treatment must be discontinued before Day 1.

• Treatment with any investigational drug within 30 days of the screening visit in this trial.

• Subject who received any of the following medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on CYP3A4.5 for clearance, and for which elevated plasma concentrations are associated with serious and or life-threatening events such as: orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).

• Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.