A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)

Tibotec Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: TMC435

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812331

CR012604

TMC435350-TiDP16-C202 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.

Full description

This is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of TMC435350 hereafter referred to as TMC435. Approximately 40 participants will be divided in 5 groups as per the genotype (8 participants each group). The study will include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase (30-35 days after the last dose of study medication). Safety evaluations will include assessment of adverse events, clinical laboratory tests and cardiovascular safety.

Enrollment: 37 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV) infection
• Participants who have never received treatment for their HCV infection
• Participants with either no cirrhosis or up to Child Pugh A liver disease
• Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at screening

Exclusion criteria

• Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices
• Participants with diagnosed or suspected hepatocellular carcinoma
• Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A or B virus infection or active tuberculosis at screening
• Participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 5 patient groups

Genotype 2

Experimental group

Description:

Participants with chronic genotype 2 hepatitis C virus (HCV) infection

Treatment:

Drug: TMC435

Genotype 3

Experimental group

Description:

Participants with chronic genotype 3 HCV infection

Treatment:

Drug: TMC435

Genotype 4

Experimental group

Description:

Participants with chronic genotype 4 HCV infection

Treatment:

Drug: TMC435

Genotype 5

Experimental group

Description:

Participants with chronic genotype 5 HCV infection

Treatment:

Drug: TMC435

Genotype 6

Experimental group

Description:

Participants with chronic genotype 6 HCV infection

Treatment:

Drug: TMC435