A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

NCT01290731 | Completed Phase 3 Results

• 2 other identifiers: CR017698TMC435HPC3008
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in Japan.

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic; Hepatitis C virus; Interferon Alfa-2a; Ribavirin; Viral RNA

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)

  The table below shows the percentage of participants with an SVR12 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) 12 weeks after the last dose of treatment (Week 36 or 60).

  Week 36 or 60

Secondary Outcomes (8)

• The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)

  Week 48 or 60

• The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up

  Days 3 and 7, Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and follow-up (FU) Weeks 4, 12, and 24

• The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)

  Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT

• The Number of Participants With Viral Breakthrough

  Day 1 until end of treatment (EOT [Week 24 or 48])

• The Number of Participants Demonstrating Viral Relapse

  Up to 72 weeks

Study Arms (1)

TMC435 100 mg 12 Wks + PR24/48

EXPERIMENTAL

Participants will receive TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment will be stopped at Week 24 in participants who achieve plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (\<) 1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants will continue PR until Week 48 (PR 48).

Drug: TMC435; Drug: Pegylated interferon (pegIFN alpha-2a); Drug: Ribavirin (RBV)

Interventions

TMC435 DRUG

100-mg capsule once daily for 12 weeks

TMC435 100 mg 12 Wks + PR24/48

Pegylated interferon (pegIFN alpha-2a) DRUG

180 mcg injected subcutaneously (by a syringe under the skin) once weekly for 12 to 36 weeks (or until Week 48).

Also known as: PEGASYS

TMC435 100 mg 12 Wks + PR24/48

Ribavirin (RBV) DRUG

200-mg tablets (daily dose: 600-1000 mg) taken orally (by mouth) two times a day for 12 to 36 weeks (or until Week 48).

Also known as: COPEGUS

TMC435 100 mg 12 Wks + PR24/48

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have chronic genotype 1 HCV with HCV RNA level \>= 5.0 log10 IU/mL
• Participant relapsed after previous IFN-based therapy
• Participant must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication.

You may not qualify if:

• Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)
• Diagnosed with hepatic cirrhosis or hepatic failure
• A medical condition which is a contraindication to pegIFN or ribavirin therapy
• History of, or any current medical condition, which could impact the safety of the patient in the study

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (10)

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Ichikawa, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Matsumoto, Japan

Location

Unknown Facility

Musashino, Japan

Location

Unknown Facility

Ohmura, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Suita, Japan

Location

Unknown Facility

Touon, Japan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Simeprevir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Manager
• Organization: Janssen Pharmaceutical K.K., Japan

81 3 44115639

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 4, 2014
• Results First Posted: February 4, 2014

Record last verified: 2013-12

Locations

JP (10)