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Hepatitis C Virus Genotype-1Phase 3NCT01479868

A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

A Phase 3 study testing TMC435, Pegylated interferon alpha-2a and Ribavirin in people with Hepatitis C Virus Genotype-1, run by Janssen R&D Ireland at 32 sites in 8 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 is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C Virus Genotype-1
What is being tested?
TMC435, Pegylated interferon alpha-2a and Ribavirin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
32 sitesin 8 countries
Study dates
Oct 2011to Aug 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • A liver biopsy required within 3 years prior to screening unless the patient has a contraindication for a liver biopsy
  • Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within 2 years prior screening must have an ultrasound taken within 2 months prior to the screening visit or during screening with no findings suspicious for hepatocellular carcinoma (HCC)
  • Genotype-1 hepatitis C virus (HCV) infection
  • Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
  • Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months prior to screening

Who cannot join

  • Patient showing evidence of hepatic decompensation (ie, history or current evidence of ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less than 3.3 gm per dL, prolonged prothrombin time [PT] expressed as international normalized ratio [INR] more than 1.5)
  • Any liver disease of non-HCV etiology
  • Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
  • An acute HIV-1 infection; or HIV-2 infection
  • Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening

Trial locations and contacts

32 sites in 8 countries.

32 sites in 8 countries

United States10 sites

  • Study site

    Albany, New York

  • Study site

    Atlanta, Georgia

  • Study site

    Chicago, Illinois

  • Study site

    Dallas, Texas

  • Study site

    Houston, Texas

  • Study site

    Los Angeles, California

  • Study site

    New York, New York

  • Study site

    Newark, New Jersey

  • Study site

    Orlando, Florida

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

Germany7 sites

  • Study site

    Berlin

  • Study site

    Bonn

  • Study site

    Cologne

  • Study site

    Düsseldorf

  • Study site

    Frankfurt

  • Study site

    Freiburg im Breisgau

  • Study site

    Hamburg

Other trials in Germany

France4 sites

  • Study site

    Lyon

  • Study site

    Montpellier

  • Study site

    Nantes

  • Study site

    Paris

Other trials in France

Portugal3 sites

  • Study site

    Amadora

  • Study site

    Lisbon

  • Study site

    Porto

Other trials in Portugal

Spain3 sites

  • Study site

    Badalona

  • Study site

    Elche

  • Study site

    Madrid

Other trials in Spain

Canada2 sites

  • Study site

    Montreal, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

United Kingdom2 sites

  • Study site

    Brighton

  • Study site

    London

Other trials in United Kingdom

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase III Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of TMC435 Plus PegIFNα-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Subjects Who Are Co-infected With Human Immunodeficiency Virus Type 1 (HIV-1)

The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.

Read the detailed description

This is an open-label (all the people know the identity of the intervention), single arm (study will be conducted in a single group) clinical study, to evaluate the safety, tolerability and efficacy of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in adult chronic hepatitis C (CHC) genotype-1 infected patients who are co-infected with human immunodeficiency virus-type 1 (HIV-1). The study consists of 3 phases, screening phase (Week -6), treatment phase, and a follow-up phase (up to 24 weeks). In the treatment phase, patients will be classified based on their experience with previous hepatitis C virus (HCV) treatment as follows: 1) HCV treatment-naive (patients who never received medication for the treatment of HCV); 2) prior HCV relapsers (patients who received at least 24 weeks of a PegIFNα-2a and RBV-based therapy and relapsed within 1 year after the last medication intake); and 3) prior HCV non-responders (can be further classified as, null responders: patients having at least 1 prior documented course of PegIFNα-2a and RBV therapy for at least 12 consecutive weeks; or partial responders: patients having at least 20 consecutive weeks which has not been discontinued due to intolerability to PegIFNα-2a and RBV therapy). All patients will receive TMC435 once daily along with PegIFNα-2a and RBV for 12 weeks. Patients who are continuing treatment only with PegIFNα-2a and RBV will follow until 24 or 48 weeks. Pharmacokinetics will be measured after collection of blood samples. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examinations, and specific toxicities will be performed throughout the study. The total duration of treatment is approximately of 24 weeks.

Being tested
TMC435, Pegylated interferon alpha-2a, Ribavirin
Keywords
Hepatitis C virus genotype-1, Human immunodeficiency virus-type 1, HCV-1, HIV-1, TMC435, Pegylated interferon alpha-2a, PegIFNα-2a, Pegasys, Ribavirin, RBV, Copegus
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

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

  • TMC435Drug

    TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.

  • Pegylated interferon alpha-2aDrug

    Pegylated interferon alpha-2a 180 microgram will be administered as subcutaneous injection of 0.5 mL until 24 to 48 weeks.

  • RibavirinDrug

    Ribavirin 1000 or 1200 mg twice daily will be administered each day until 24 to 48 weeks.

Study groups in NCT01479868
Study groupRoleWhat they receive
TMC435 + pegylated interferon alpha-2a + ribavirinExperimentalPatients will be administered TMC435 150 mg along with pegylated interferon alpha-2a 180 microgram and ribavirin 1000 or 1200 mg for 12 weeks. Pegylated interferon alpha-2a and ribavirin will only be continued until 24 to 48 weeks.
Receives: Drug: TMC435; Drug: Pegylated interferon alpha-2a; Drug: Ribavirin

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)

    The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 12 Weeks after end of treatment.

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

Secondary outcomes (11)

  1. Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)

    The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment.

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

  2. Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable

    Percentage of participants with HCV RNA less than (<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed.

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

  3. Percentage of Participants With On-treatment Failure

    Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels.

    Measured: Week 1 to 48

  4. Percentage of Participants With Viral Breakthrough

    Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy.

    Measured: Week 1 to 48

  5. Percentage of Participants With Viral Relapse

    Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL.

    Measured: Week 1 to 72

  6. Percentage of Participants With Normalized Alanine Aminotransferase Levels

    Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline.

    Measured: Baseline up to Week 72

  7. Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure

    Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL.

    Measured: Baseline to Week 72.

  8. Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load

    Measured: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72

  9. Mean Change From Baseline in CD4+ Cell Count

    Measured: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72

  10. Change From Baseline in CD4+ Cell Count in Percentage

    Measured: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72

  11. Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state.

    Measured: Week 1 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 posted28 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionAug 2013
  4. Study completionAug 2013

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
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01479868
Sponsor's protocol ID
CR018334
Other IDs
TMC435-TiDP16-C212
Status last verified
Oct 2014
First submitted
18 Oct 2011
Last updated
29 Oct 2014
Data monitoring committee
No

Publications

  • Andersohn F, Claes AK, Kulp W, Mahlich J, Rockstroh JK. Simeprevir with pegylated interferon alfa 2a plus ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a meta-analysis and historical comparison. BMC Infect Dis. 2016 Jan 11;16:10. doi: 10.1186/s12879-015-1311-3.

    PubMed 26753774

  • Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.

    PubMed 26743093

  • Dieterich D, Rockstroh JK, Orkin C, Gutierrez F, Klein MB, Reynes J, Shukla U, Jenkins A, Lenz O, Ouwerkerk-Mahadevan S, Peeters M, De La Rosa G, Tambuyzer L, Jessner W. Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study. Clin Infect Dis. 2014 Dec 1;59(11):1579-87. doi: 10.1093/cid/ciu675. Epub 2014 Sep 5.

    PubMed 25192745

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TMC435, Pegylated interferon alpha-2a and Ribavirin in people with Hepatitis C Virus Genotype-1, run by Janssen R&D Ireland at 32 sites in 8 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 5 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Germany, France, Portugal, Spain and 3 more countries. 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?

Yes. Results are posted in the registry (first posted 29 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12) (time frame: 12 weeks after end of treatment (Week 24 or 48)). 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 NCT01479868, which also lists 3 linked publications.

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 29 Oct 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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