MedTrace Logo

A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

NCT01846832 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2016-09-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.

Conditions

Interventions

DRUG

TMC435

150 mg taken orally (by mouth) as a capsule with food once daily for 12 weeks.

DRUG

Pegylated interferon alfa-2a (PegIFNα-2a)

180 mcg administered according to the manufacturer's prescribing information as a 0.5 mL subcutaneous (under the skin) (SC) injection once a week in the morning or evening for up to 24 weeks.

DRUG

Ribavirin (RBV)

1000 mg or 1200 mg administered according to the manufacturer's prescribing information for up to 24 weeks. If the participant's baseline body weight is \< 75 kg, the total daily dose of RBV will be 1000 mg, administered orally (by mouth) as 400 mg (2 tablets of 200 mg, intake with food) in the morning and 600 mg (3 tablets of 200 mg, intake with food) in the evening. If the baseline body weight is \> or = 75 kg, the total daily dose will be 1200 mg, administered as 600 mg in the morning and evening (3 tablets of 200 mg per intake, with food).

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • JJanssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Saudi Arabia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01846832 on ClinicalTrials.gov