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 + ribavirin

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 + ribavirin - TMC649128/interferon/ribavirin in HCV patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35874

Enrollment

Registered

2011-05-12

Start date

2011-07-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis C liver disease

Interventions

Monotherapy phase Panel 1: TMC649128 at 1000 mg q24h (n=8) or placebo (n=2) q24h on Days 1-10 under fed conditions Panel 2: TMC649128 at 1600 mg (n=8) or placebo (n=2) q12h on Days 1-14 under fed co

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)