Overview

A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus Infection

Status:
Completed

Trial end date:
2010-05-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to investigate how efficient TMC435350 will work against the Hepatitis C virus genotype 1 (genotypes refer to the genetic constitution of the virus) and what the concentrations of TMC435350 in the blood are with or without pegylated interferon alpha-2a (PegIFNa-2a) or PegIFNa-2a plus ribavirin.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Tibotec Pharmaceuticals, Ireland

Treatments:

Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Simeprevir

Criteria

Inclusion Criteria: - Documented chronic genotype 1 Hepatitis C infection - Able to comply
with the protocol requirements and having good accessible veins - Amount of virus in the
blood (HCV RNA) >= 10.000 IU/mL, at screening - Bodyweight as defined by a Quetelet Index
(Body Mass Index [BMI]) between 18 and 32 kg/m², extremes included Exclusion Criteria: -
Evidence of liver cirrhosis or decompensated liver disease or any other form of non-viral
hepatitis - Participants receiving or having received treatment with polymerase inhibitor
or protease inhibitor, or Standard of Care therapy with COPEGUS (ribavirin) and PEGASYS
(peginterferon alpha-2a) for treatment for HCV during the 6 months before screening - Male
participants with female partners of childbearing potential not agreeing to use a reliable
birth control method, Female, except if postmenopausal for over 2 years, or
posthysterectomy, or post-tubal ligation (without reversal operation) - History or evidence
of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use,
which would compromise the participant 's safety and/or compliance. A positive urine drug
test at screening. Urine will be tested to check the current use of amphetamines, cocaine,
and opioids (with the exclusion of methadone) - Participants having at least one lab
toxicity that is found to be clinically significant - Participants co-infected with HIV, or
Hepatitis A or B, or hepatitis B surface antigen, or active tuberculosis at screening,
participants with prolonged QTc (>480 ms) value or any cardiac disease at screening, or any
active clinically significant disease (e.g., cardiac dysfunction, cardio(myo)pathy, cardiac
insufficiency), or medical history or physical examination findings during screening that,
in the Investigator's opinion, would compromise the outcome of the trial - Participants
having uncontrolled/unstable diabetes, epilepsy, a manifest psychiatric disease, non-stable
methadone (or equivalent drug) use or participants having any other unstable disease,
participants enrolled in another clinical trial within 90 days prior to screening