A Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Patients

• Status: Completed
• Trial end date: 2014-03-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study to evaluate the efficacy, safety and tolerability of TMC435 in combination with Peginterferon alfa-2a (PegINF alfa-2a) and ribavirin (RBV) in both treatment-naïve and treatment experienced, chronic hepatitis C (HCV) virus, genotype-4 infected patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen R&D Ireland
• Treatments: Peginterferon alfa-2a; Ribavirin; Simeprevir

Criteria

Inclusion Criteria:

• Genotype 4 Hepatitis C virus (HCV) infection (confirmed at screening)

• Plasma HCV ribonucleic acid (RNA) of >10,000 IU/mL at screening

• Participants should be either treatment-naïve or treatment-experienced (non-responder or relapser) with adequate documentation of previous response

• Participants must have voluntarily signed an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. To participate in the optional pharmacogenomic component in this study (exploratory host genotyping), participants must have voluntarily signed a separate ICF for this component (where local regulations permit). Refusal to give consent for this component does not exclude a participant from participation in the core study.

• Participants must have had a liver biopsy within 3 years prior to screening (or between screening and baseline visit) with histology consistent with chronic HCV infection

Exclusion Criteria:

• Has an infection/co-infection with non-genotype 4 HCV

• Has a co-infection with Human Immunodeficiency Virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).

• Has any of the following laboratory abnormalities:

1. Platelet count <90,000/mm3;

2. Absolute neutrophil count (ANC) <1500 cells/mm3 (Blacks: <1200 cells/mm3);

3. Hemoglobin <12 g/dL for women and <13 g/dL for men;

4. Creatinine >1.5 mg/dL;

5. ALT and/or AST >10 x upper limit of normal (ULN);

6. Total serum bilirubin >1.5 x ULN;

7. Alpha-fetoprotein [AFP] >50 ng/mL;

8. Albumin plasma concentration <3.5 g/dL;

9. Prothrombin time (PT) expressed as international normalized ratio (INR) >1.5. Note: retesting of abnormal laboratory values that leads to exclusion will be allowed once using an unscheduled visit during the screening period to assess eligibility.

• Used disallowed concomitant therapy

• Has evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)