A Phase Ib, double-blind, randomized, placebo-controlled trial in genotype 1 HCV-infected patients to determine the safety, tolerability, pharmacokinetics and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribaviri

Completed

• Conditions: liver disease; hepatitis C; 10047438

• Registration Number: NL-OMON35874
• Lead Sponsor: PRA International EDS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Hepatitis C infected patients
Genotype 1
18-65 year
BMI 18.0 - 35.0 kg/m2

Exclusion Criteria

positive for Hepatitis B or HIV
except from hepatitis C infection diagnosed as not-healthy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics:<br /><br>HCV RNA levels, intracellular triphosphate (TMC652337) in PMBC*s, safety<br /><br>parameters<br /><br><br /><br>Pharmacokinetics:<br /><br>plasma and derived urine TMC649128, TMC619688 and TMC649129 concentrations,<br /><br>whole blood concentration of TMC649128, plasma concentrations of RBV, derived<br /><br>plasma and whole blood pharmacokinetic parameters<br /><br><br /><br>Safety:<br /><br>adverse events, vital signs, ECG-parameters, laboratory parameters, physical<br /><br>examination<br /><br><br /><br>Anti-viral activity:<br /><br>HCV RNA levels</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>