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Hepatitis CPhase 3RESTORENCT01567735

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

A Phase 3 study testing TMC435 in people with Hepatitis C, run by Janssen R&D Ireland at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C
What is being tested?
TMC435
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
8 sitesin 2 countries
Study dates
27 Mar 2012to 20 Mar 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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;
  • 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)

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

France5 sites

  • Study site

    Clichy

  • Study site

    Créteil

  • Study site

    Lyon

  • Study site

    Paris

  • Study site

    Villejuif

Other trials in France

Belgium3 sites

  • Study site

    Antwerp

  • Study site

    Brussels

  • Study site

    Edegem

Other trials in Belgium

About this study

Official title: An Open-Label, Single-Arm Phase III 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 Subjects

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.

Read the detailed description

This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single arm Phase III study, with 3 subpopulations: treatment naive, previous HCV relapser and previous HCV non-responders. The study will consist of 3 phases: a screening phase of maximum 6 Weeks, an open-label treatment phase of 24 to 48 Weeks for treatment naive patients and relapsers (response guided treatment) and 48 Weeks for non-responders, followed by a 24 Week follow-up period. The duration of participation in the study for an individual participant will be up to 54 to 78 (including screening).

Part Ia: All participants will receive 12 Weeks of triple therapy with TMC435 (150mg once daily [q.d.]), PegINF-alfa-2a (180µg per Week) and RBV (1000 to 1200 mg per day, based on weight), followed by 12 Weeks of PegINF-alfa-2a (180µg per Week) and RBV (1000 to 1200 mg per day, based on weight).

Part Ib: Participants who will need to continue treatment for another 24 Weeks (non-responders + treatment naive and relapser patients who need to continue treatment according to the response guided treatment criteria) will receive an additional 24 Weeks of PegINF-alfa 2a (180 mg per Week) and RBV (1000 to 1200 mg per day, based on weight).

Part II: 24 Week follow-up period for all participants, starting after Week 24 or Week 48.

In Part Ia, participants will have to come for 6 visits during the first month, followed by a visit once every month until Week 24 (in total 11 visits- Day1, day 3, Day 7, Day 14, day 28, Week 8, Week 12, Week 16, Week 20 and Week 24) at which safety, efficacy and tolerability will be checked.

In Part Ib, participants will have to come for 4 additional visits (Week 28, Week 36, Week 42 and Week 48) at which safety, tolerability and efficacy will be checked In the follow-up period, participants will have to come for an additional 3 visits (either Week 28, Week 36 and Week 28 or Week 52, Week 60 and Week 72) at which safety and efficacy will be checked.

Participants who withdraw prematurely will have a visit at withdrawal, 4 Weeks after withdrawal and then every 12 Weeks until 72 Weeks after baseline at which safety will be checked.

Conditions
Hepatitis C
Being tested
TMC435
Keywords
Hepatitis C, TMC435HPC3011, TMC435
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMC435Drug

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

Study groups in NCT01567735
Study groupRoleWhat they receive
TMC435ExperimentalNot described
Receives: Drug: TMC435

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to Week 60

Secondary outcomes (6)

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

    To evaluate the proportion of participants with SVR24, assessed 24 weeks after the planned end of treatment, in the overall population as well as in the different subpopulations

    Measured: Up to Week 72

  2. On-treatment virologic response

    To evaluate on-treatment virologic response at all time points with focus on Week 4, Week 12, Week 24, Week 36, Week 48, in the overall population as well as in the different subpopulations.

    Measured: Week 4, Week 12, Week 24, Week 36, Week 48

  3. On-treatment virologic failure

    To evaluate on-treatment virologic failure in the overall population as well as in the different subpopulations.

    Measured: Up to Week 48

  4. Evaluation of the viral breakthrough rate

    To evaluate the viral breakthrough rate on TMC435 in combination with PegIFNα-2a/RBV in the overall population as well as in the different subpopulations

    Measured: Up to Week 48

  5. Evaluation of viral relapse rate

    To evaluate the relapse rate after TMC435 in combination with PegIFNα-2a/RBV in the overall population as well as in the different subpopulations

    Measured: Up to Week 48

  6. Evaluation the safety and tolerability

    To evaluate the safety (includes adverse events, clinical lab tests, ECG and vital signs) and tolerability of TMC435 in combination with PegIFNα-2a/RBV

    Measured: Up to Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2012 (estimated)
  2. Study start27 Mar 2012
  3. Primary completion20 Mar 2014
  4. Study completion20 Mar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01567735
Sponsor's protocol ID
CR100695
Other IDs
TMC435HPC3011, 2011-004097-29
Acronym
RESTORE
Status last verified
Jul 2017
First submitted
24 Jan 2012
Last updated
7 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 25596313

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TMC435 in people with Hepatitis C, run by Janssen R&D Ireland at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving sustained virologic response 12 weeks after planned end of treatment (SVR12) (time frame: Up to Week 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01567735, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.

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