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Hepatitis CPhase 3ATTAINNCT01485991

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

A Phase 3 study testing TMC435 and TVR in people with Hepatitis C, run by Janssen R&D Ireland at 137 sites in 24 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN. 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 and TVR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
771 participants
Where
137 sitesin 24 countries
Study dates
Feb 2012to Apr 2014
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

  • Patient must have had a liver biopsy before screening (or between the screening and baseline visit), unless patient cannot undergo such a procedure or has evidence of portal hypertension not associated with cirrhosis. For patients who had a liver biopsy performed more than 2 years prior to screening or without a biopsy (because of a contraindication or portal hypertension), a non-invasive staging assessment needs to be available. Non-invasive staging assessments include FibroScan, MR-Elastography, or FibroTest/FibroSure and must not be older than 6 months prior to screening
  • Chronicity of hepatitis C virus (HCV) infection, as confirmed by one or both of the following: presence of anti-HCV antibody and/or HCV ribonucleic acid (RNA) at least 6 months prior to the screening visit and/or presence of fibrosis on biopsy
  • Genotype 1 HCV infection with plasma HCV RNA of >10,000 IU/mL (both confirmed at screening)
  • Patient must have had at least 1 documented previous course of treatment with PegINFα-2a or PegINFα-2b in combination with ribavirin (RBV) (at least 12 weeks for null responder and 20 weeks for partial responder)

Who cannot join

  • Hepatic decompensation (impaired functioning of the liver), as indicated by significant laboratory abnormalities or other active diseases
  • Infection with Human Immunodeficiency Virus (HIV) or non genotype 1 hepatitis C
  • Liver disease not related to hepatitis C infection
  • Previous chronic hepatitis C treatment, other than PegIFN and RBV

Trial locations and contacts

137 sites in 24 countries.

137 sites in 24 countries

United States32 sites

  • Study site

    Allentown, Pennsylvania

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Bakersfield, California

  • Study site

    Bellevue, Washington

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Falls Church, Virginia

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Jackson, Mississippi

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    Missoula, Montana

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Newark, New Jersey

  • Study site

    Odessa, Texas

  • Study site

    Orlando, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Rochester, New York

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Seattle, Washington

  • Study site

    Tupelo, Mississippi

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Palm Beach, Florida

Other trials in United States

Germany12 sites

  • Study site

    Berlin

  • Study site

    Frankfurt

  • Study site

    Freiburg im Breisgau

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    Kiel

  • Study site

    Mainz

  • Study site

    München

  • Study site

    Stuttgart

  • Study site

    Ulm

  • Study site

    Würzburg

Other trials in Germany

Australia8 sites

  • Study site

    Darlinghurst

  • Study site

    Greenslopes

  • Study site

    Kingswood

  • Study site

    Melbourne

  • Study site

    Parkville - Vic

  • Study site

    Perth

  • Study site

    Sydney

  • Study site

    Woolloongabba

Other trials in Australia

Poland8 sites

  • Study site

    Bydgoszcz

  • Study site

    Chorzów

  • Study site

    Kielce

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Mysłowice

  • Study site

    Racibórz

  • Study site

    Warsaw

Other trials in Poland

France7 sites

  • Study site

    Grenoble

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Israel6 sites

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Safed

  • Study site

    Tel Aviv

Other trials in Israel

United Kingdom6 sites

  • Study site

    Glasgow

  • Study site

    Leeds

  • Study site

    London

  • Study site

    Newcastle upon Tyne

  • Study site

    Plymouth

  • Study site

    Southampton

Other trials in United Kingdom

Canada5 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Montreal, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Kaposvár

  • Study site

    Pécs

  • Study site

    Szeged

Other trials in Hungary

Spain5 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Santander

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

Sweden5 sites

  • Study site

    Gothenburg

  • Study site

    Lund

  • Study site

    Malmö

  • Study site

    Örebro

  • Study site

    Stockholm

Other trials in Sweden

Belgium4 sites

  • Study site

    Brussels

  • Study site

    Haine-Saint-Paul, La Louviere

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Brazil4 sites

  • Study site

    Campinas

  • Study site

    Ribeirão Preto

  • Study site

    Salvador

  • Study site

    São Paulo

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Czechia4 sites

  • Study site

    Brno

  • Study site

    Karlovy Vary

  • Study site

    Pilsen

  • Study site

    Prague

Other trials in Czechia

Norway4 sites

  • Study site

    Fredrikstad

  • Study site

    Nordbyhagen

  • Study site

    Stavanger

  • Study site

    Tromsø

Other trials in Norway

Romania4 sites

  • Study site

    Bucharest

  • Study site

    Constanța

  • Study site

    Iași

  • Study site

    Timișoara

Other trials in Romania

Denmark3 sites

  • Study site

    Copenhagen

  • Study site

    Hvidovre

  • Study site

    Odense

Other trials in Denmark

Greece3 sites

  • Study site

    Alexandroupoli

  • Study site

    Athens

  • Study site

    Larissa

Other trials in Greece

Switzerland3 sites

  • Study site

    Lugano

  • Study site

    Sankt Gallen

  • Study site

    Zurich

Other trials in Switzerland

Argentina2 sites

  • Study site

    Buenos Aires

  • Study site

    Rosario, Santa Fe

Other trials in Argentina

Austria2 sites

  • Study site

    Linz

  • Study site

    Vienna

Other trials in Austria

Bulgaria2 sites

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Portugal2 sites

  • Study site

    Lisbon

  • Study site

    Porto

Other trials in Portugal

Puerto Rico1 site

  • Study site

    Santurce

Other trials in Puerto Rico

About this study

Official title: Phase III in Partial and Null Responders

The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

Read the detailed description

This study is a randomized (study drug assigned by chance like flipping a coin), double-blind (neither physician nor patient knows the name of the assigned drug), double-dummy (patients receive both active and inactive pills also called placebo), 2-arm, multicenter Phase III clinical study in adult treatment experienced Chronic Hepatitis C (CHC) genotype-1 infected patients who failed to respond during at least 1 previous course of PegINFα-2a/ RBV therapy. The purpose of the trial is to study the efficacy of TMC435 in combination with PegINFα-2a and RBV for 48 weeks of treatment compared to the approved regimen of telaprevir in combination with PegINFα-2a and RBV for 48 weeks of treatment. The study will consist of a screening period (maximum 6 weeks), treatment period (48 weeks) and post-treatment period (until 72 weeks after the start of treatment). For the first 12 weeks one group of patients will take TMC435 and TVR placebo, plus PegINFα-2a and RBV. The other group will take TMC435 placebo and TVR, plus PegINFα-2a and RBV. After 12 weeks, patients in both arms will only take PegINFα-2a and RBV up to week 48. After patients stop taking study medication, they will continue to go to the doctor's office for study visits until a total of 72 weeks after they start study treatment. Patients will be monitored for safety throughout the study. Study assessments at each study visit may include, but are not limited to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical activity of your heart), patient questionnaires, and physical examinations.

Conditions
Hepatitis C
Being tested
TMC435, TVR
Keywords
Hepatitis C, TMC435HPC3001, TMC435, Hepatitis C Virus (HCV), HEP C, Genotype 1, Treatment experienced, Null responders, Partial responders
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

    TMC435 Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TVR placebo Form=tablet, route=oral use. TMC435 capsule is taken once daily in addition to 2 TVR placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.

  • TVRDrug

    TVR Type=exact number, unit=mg, number=375, form=tablet, route=oral use. TMC435 placebo Form=capsule, route=oral use. 2 TVR tablets are taken 3 times a day together with 150 mg TMC435 placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks

Study groups in NCT01485991
Study groupRoleWhat they receive
TMC435/PRExperimentalNot described
Receives: Drug: TMC435
TVR/PRActive comparatorNot described
Receives: Drug: TVR

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 12 Weeks After the Planned End of Treatment (SVR12)

    Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable.

    Measured: 12 Weeks After the Planned End of Treatment (EOT: Week 48)

Secondary outcomes (2)

  1. Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)

    Participants are considered to have reached SVR24 if both conditions below are met: 1) HCV RNA levels less than <25 International unit per milliliter (IU/mL) undetectable (at the actual end of treatment);2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable (24 weeks after the planned EOT).

    Measured: 24 Weeks After the Planned EOT (Week 48)

  2. Percentage of Participants With Viral Relapse

    Participants are considered to have a viral relapse if both conditions as specified are met: 1) <25 IU/mL undetectable HCV RNA at the actual end of study drug treatment; 2) confirmed HCV RNA greater than or equal to (>=) 25 IU/mL during follow-up.

    Measured: End of Treatment (Week 48) up to Follow-up Period (until 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 posted6 Dec 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionApr 2014
  4. Study completionApr 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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
771 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01485991
Sponsor's protocol ID
CR100677
Other IDs
TMC435HPC3001
Acronym
ATTAIN
Status last verified
Mar 2016
First submitted
25 Nov 2011
Last updated
26 Apr 2016
Data monitoring committee
Yes

Publications

  • Reddy KR, Zeuzem S, Zoulim F, Weiland O, Horban A, Stanciu C, Villamil FG, Andreone P, George J, Dammers E, Fu M, Kurland D, Lenz O, Ouwerkerk-Mahadevan S, Verbinnen T, Scott J, Jessner W. Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial. Lancet Infect Dis. 2015 Jan;15(1):27-35. doi: 10.1016/S1473-3099(14)71002-3. Epub 2014 Dec 5.

    PubMed 25482330

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TMC435 and TVR in people with Hepatitis C, run by Janssen R&D Ireland at 137 sites in 24 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 4 inclusion and 4 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, Germany, Australia, Poland, France and 19 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 10 Apr 2015). 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 12 Weeks After the Planned End of Treatment (SVR12) (time frame: 12 Weeks After the Planned End of Treatment (EOT: Week 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 NCT01485991, 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 26 Apr 2016.

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