NCT01567735

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2012

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2014

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

January 24, 2012

Last Update Submit

July 5, 2017

Conditions

Hepatitis C

Keywords

Hepatitis CTMC435HPC3011TMC435

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants achieving sustained virologic response 12 weeks after planned end of treatment (SVR12)

    The primary objective is to evaluate the efficacy of TMC435 in combination with pegylated interferon alpha-2a (PegIFNα 2a)/ribavirin (RBV) with respect to the proportion of participants with chronic HCV-4 infection achieving SVR 12 weeks after planned end of treatment (SVR12) in the overall population as well as in the different subpopulations (treatment-naïve, previous relapsers and previous non-responders).

    Up to Week 60

Secondary Outcomes (6)

  • Efficacy of TMC435 with respect to proportion of participants achieving sustained virologic response 24 weeks after planned end of treatment (SVR24)

    Up to Week 72

  • On-treatment virologic response

    Week 4, Week 12, Week 24, Week 36, Week 48

  • On-treatment virologic failure

    Up to Week 48

  • Evaluation of the viral breakthrough rate

    Up to Week 48

  • Evaluation of viral relapse rate

    Up to Week 48

  • +1 more secondary outcomes

Study Arms (1)

TMC435

EXPERIMENTAL
Drug: TMC435

Interventions

TMC435DRUG

Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TMC435 capsule is taken once daily for 12 weeks.

TMC435

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Platelet count \<90,000/mm3;
  • Absolute neutrophil count (ANC) \<1500 cells/mm3 (Blacks: \<1200 cells/mm3);
  • Hemoglobin \<12 g/dL for women and \<13 g/dL for men;
  • Creatinine \>1.5 mg/dL;
  • ALT and/or AST \>10 x upper limit of normal (ULN);
  • Total serum bilirubin \>1.5 x ULN;
  • Alpha-fetoprotein \[AFP\] \>50 ng/mL;
  • Albumin plasma concentration \<3.5 g/dL;
  • Used disallowed concomitant therapy
  • Has evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Edegem, Belgium

Location

Unknown Facility

Clichy, France

Location

Unknown Facility

Créteil, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Villejuif, France

Location

Related Publications (1)

  • Moreno C, Hezode C, Marcellin P, Bourgeois S, Francque S, Samuel D, Zoulim F, Grange JD, Shukla U, Lenz O, Ouwerkerk-Mahadevan S, Fevery B, Peeters M, Beumont M, Jessner W. Efficacy and safety of simeprevir with PegIFN/ribavirin in naive or experienced patients infected with chronic HCV genotype 4. J Hepatol. 2015 May;62(5):1047-55. doi: 10.1016/j.jhep.2014.12.031. Epub 2015 Jan 14.

    PMID: 25596313RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

Simeprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Janssen R&D Ireland Clinical Trial

    Janssen R&D Ireland

    STUDY DIRECTOR

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

January 24, 2012

First Posted

March 30, 2012

Study Start

March 27, 2012

Primary Completion

March 20, 2014

Study Completion

March 20, 2014

Last Updated

July 7, 2017

Record last verified: 2017-07

Locations

FR(5)BE(3)