Overview

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.