An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients

NCT01725529 | Completed Phase 3 Results DMC

• 2 other identifiers: CR017962TMC435HPC3005
• Study Type: interventional
• Target: 457
• Locations: 2 countries
• Sites: 21

Brief Summary

The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) in patients with genotype 1 Hepatitis C virus (HCV) infection.

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic; TMC435; Ribavirin; peginterferon-alpha (PegIFNα-2a)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)

  Participants considered to have achieved SVR12 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (\<) lower limit of quantification (LLOQ; 25 international unit per milliliter \[IU/mL\]) undetectable at end of treatment and, 2). the HCV RNA is \< LLOQ detectable or undetectable at 12 weeks after the planned end of study drug treatment.

  12 weeks after the end of treatment (EOT: Week 24 or 48)

Secondary Outcomes (6)

• Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24)

  24 weeks after the end of treatment (EOT: Week 24 or 48)

• Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72)

  Week 72

• Percentage of Participants With On-treatment Failure

  End of Treatment (EOT: Week 24 or 48)

• Percentage of Participants With Viral Breakthrough

  Week 24 or 48 (End of Treatment)

• Percentage of Participants With Viral Relapse

  72 weeks after the EOT (Week 24 or 48)

Study Arms (3)

TMC435 150 mg

EXPERIMENTAL

Patients will receive 12 weeks TMC435 150 mg once daily (q.d.) plus peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV), followed by PegIFNα-2a and RBV alone. Response-guided treatment criteria will be used to determine total treatment duration of 24 or 48 weeks for patients in the TMC435 treatment groups. Patients in the control group will continue to receive treatment with PegIFNα-2a and RBV until Week 48.

Drug: TMC435; Drug: Peginterferon-alpha (PegIFNα-2a); Drug: Ribavirin (RBV)

TMC435 100 mg

EXPERIMENTAL

Patients will receive 12 weeks TMC435 100 mg once daily (q.d.) plus peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV), followed by PegIFNα-2a and RBV alone. Response-guided treatment criteria will be used to determine total treatment duration of 24 or 48 weeks for patients in the TMC435 treatment groups. Patients in the control group will continue PegIFNα-2a and RBV until Week 48.

Drug: TMC435; Drug: Peginterferon-alpha (PegIFNα-2a); Drug: Ribavirin (RBV)

Control

PLACEBO COMPARATOR

Patients will receive placebo once daily (q.d.) plus peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) for 48 weeks.

Drug: Peginterferon-alpha (PegIFNα-2a); Drug: Ribavirin (RBV); Drug: Placebo

Interventions

TMC435 DRUG

TMC435 100 mg or 150 mg capsules taken orally (by mouth) with food once-daily for 12 weeks (Week 12).

TMC435 100 mg; TMC435 150 mg

Peginterferon-alpha (PegIFNα-2a) DRUG

PegIFNα-2a (180 micrograms \[μg\] once weekly) administered as weekly subcutaneous (s.c.) (under the skin) injections of 0.5 mL for 24 or 48 weeks.

Control; TMC435 100 mg; TMC435 150 mg

Ribavirin (RBV) DRUG

Ribavirin 1000 or 1200 mg/day (taken as 100 mg or 200 mg tablets) depending on body weight (If body weight is \< 75 kg the total daily dose of RBV will be 1000 mg, administered as 400 mg intake with food in the morning and 600 mg intake with food in the evening. If body weight is \> or = 75 kg the total daily dose will be 1200 mg, administered as 2 x 600 mg per intake with food, morning and evening) for 24 or 48 weeks.

Control; TMC435 100 mg; TMC435 150 mg

Placebo DRUG

Matching placebo capsules taken orally with food once-daily for 48 weeks.

Control

Eligibility Criteria

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

You may qualify if:

• A liver biopsy within 3 years prior to the screening visit (or between screening and day of randomization) with histology consistent with chronic Hepatitis C virus (HCV) infection
• Presence of contraindications for a liver biopsy in patients who are otherwise deemed eligible for participation does not exclude the patient from participation
• Genotype 1 HCV infection (confirmed at screening)
• Plasma HCV RNA of \> 10,000 IU/mL at screening

You may not qualify if:

• Prior treatment with any approved or investigational drug for the treatment of hepatitis C
• Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (21)

Unknown Facility

Beijing, China

Location

Unknown Facility

Changchun, China

Location

Unknown Facility

Changsha, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Harbin, China

Location

Unknown Facility

Jinan, China

Location

Unknown Facility

Lanzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Shenyang, China

Location

Unknown Facility

Tianjin, China

Location

Unknown Facility

Wuhan, China

Location

Unknown Facility

Zhengzhou, China

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Chuncheon, Gangwon-Do, South Korea

Location

Unknown Facility

Gyeongsangnam-Do, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Simeprevir; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; 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: ASSOCIATE DIRECTOR, MEDICAL DEPARTMENT
• Organization: Janssen R&D US

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen R&D Ireland Clinical Trial

  Janssen R&D Ireland

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 14, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 13, 2015
• Results First Posted: August 13, 2015

Record last verified: 2015-07

Locations

KR (5); CN (16)