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Hepatitis C, ChronicPhase 3NCT00703118

A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

A Phase 3 study testing Telaprevir, Peg-IFN-alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Tibotec BVBA at 91 sites in 16 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 determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Telaprevir, Peg-IFN-alfa-2a and Ribavirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
663 participants
Where
91 sitesin 16 countries
Study dates
Oct 2008to Jul 2010
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 chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL
  • Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
  • Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Who cannot join

  • Patient is a previous non-responder that is classified as a viral breakthrough case
  • Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
  • Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
  • Evidence of decompensated liver disease
  • Patient has condition that requires use of systemic corticosteroids

Trial locations and contacts

91 sites in 16 countries.

91 sites in 16 countries

United States31 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Bradenton, Florida

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Columbia, South Carolina

  • Study site

    Coronado, California

  • Study site

    Dallas, Texas

  • Study site

    Detroit, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    Egg Harbor Twp, New Jersey

  • Study site

    Falls Church, Virginia

  • Study site

    Gainesville, Florida

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Kansas City, Missouri

  • Study site

    La Jolla, California

  • Study site

    Los Angeles, California

  • Study site

    Manhasset, New York

  • Study site

    Miami, Florida

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plymouth, Minnesota

  • Study site

    Richmond, Virginia

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California

  • Study site

    Worcester, Massachusetts

Other trials in United States

France9 sites

  • Study site

    Clichy

  • Study site

    Créteil

  • Study site

    Grenoble

  • Study site

    Lille

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Australia8 sites

  • Study site

    Adelaide

  • Study site

    Camperdown

  • Study site

    Clayton

  • Study site

    Darlinghurst

  • Study site

    Kingswood

  • Study site

    Melbourne

  • Study site

    Parkville - Vic

  • Study site

    Perth

Other trials in Australia

Germany8 sites

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Düsseldorf

  • Study site

    Frankfurt

  • Study site

    Freiburg im Breisgau

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    München

Other trials in Germany

Israel5 sites

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Petah Tikva

  • Study site

    Safed

  • Study site

    Tel Aviv

Other trials in Israel

Poland5 sites

  • Study site

    Bialystok

  • Study site

    Czeladź

  • Study site

    Kielce

  • Study site

    Lodz

  • Study site

    Warsaw

Other trials in Poland

Brazil4 sites

  • Study site

    Distrito Barao Geraldo-Campina

  • Study site

    Salvador

  • Study site

    Santo André

  • Study site

    São Paulo

Other trials in Brazil

Spain4 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

Other trials in Belgium

Canada3 sites

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Netherlands3 sites

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Leiden

  • Study site

    Nijmegen

Other trials in Netherlands

Austria2 sites

  • Study site

    Graz

  • Study site

    Vienna

Other trials in Austria

Switzerland2 sites

  • Study site

    Sankt Gallen

  • Study site

    Zurich

Other trials in Switzerland

United Kingdom2 sites

  • Study site

    Birmingham

  • Study site

    London

Other trials in United Kingdom

Puerto Rico1 site

  • Study site

    Santurce

Other trials in Puerto Rico

Sweden1 site

  • Study site

    Stockholm

Other trials in Sweden

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

Read the detailed description

This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment. Standard treatment is defined as treatment with Peg-INF and RBV. The trial is designed to compare the efficacy, safety, and tolerability of 2 regimens of telaprevir (with and without delayed start) combined with standard treatment versus standard treatment alone. The trial will consist of a screening period of approximately 4 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they (1) had an undetectable HCV Ribonucleic Acid (RNA) level at the end of a prior course of standard treatment but did not achieve a response (viral relapsers), or (2) never had an undetectable HCV RNA level during or at the end of a prior course of standard treatment (non-responders). Approximately 650 patients (350 prior relapsers and 300 prior non-responders) will be randomized in a 2:2:1 ratio to one of 3 treatment groups: Treatment group A will receive telaprevir with standard treatment for 12 weeks; followed by placebo with standard treatment for 4 weeks; followed by standard treatment for 32 weeks. Treatment group B will receive placebo with standard treatment for 4 weeks; followed by telaprevir with standard treatment for 12 weeks; followed by standard treatment for 32 weeks. Treatment group C will receive placebo with standard treatment for 16 weeks; followed by standard treatment for 32 weeks. In both telaprevir regimens (A and B), patients will receive 12 weeks of 750 mg of telaprevir every 8 hours along with 48 weeks of standard treatment. Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks.

Being tested
Telaprevir, Peg-IFN-alfa-2a, Ribavirin, Placebo
Keywords
Hepatitis C, Chronic, Telaprevir, Peg-IFN-alfa-2a, Ribavirin
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • TelaprevirDrug

    Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.

  • Peg-IFN-alfa-2aDrug

    Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.

  • RibavirinDrug

    Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.

  • PlaceboDrug

    Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.

Study groups in NCT00703118
Study groupRoleWhat they receive
Group A: T12/PR48ExperimentalParticipants will receive 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.
Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2a; Drug: Ribavirin; Drug: Placebo
Group B: T12(DS)/PR48ExperimentalParticipants will receive 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.
Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2a; Drug: Ribavirin; Drug: Placebo
Group C: Pbo/PR48ExperimentalParticipants will receive placebo in combination with Peg- IFN-alfa-2a and ribavirin for 16 weeks. Participants will receive Peg- IFN-alfa-2a and ribavirin for next 32 weeks.
Receives: Drug: Peg-IFN-alfa-2a; Drug: Ribavirin; Drug: Placebo

What is being measured

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

  1. Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned

    SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.

    Measured: Week 72

Secondary outcomes (7)

  1. Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4

    RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.

    Measured: Week 4

  2. Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)

    Measured: Week 48

  3. Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned

    SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).

    Measured: Week 60

  4. Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8

    Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.

    Measured: Week 4, Week 6, or Week 8

  5. Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)

    Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).

    Measured: Up to Week 72

  6. Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4

    Measured: Baseline (Day 1) to Week 4

  7. Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12

    Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.

    Measured: Week 4 and Week 12

Timeline

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

  1. First posted23 Jun 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2010
  4. Study completionJul 2010

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
663 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00703118
Sponsor's protocol ID
CR014842
Other IDs
VX-950-TIDP24-C216
Status last verified
Dec 2013
First submitted
19 Jun 2008
Last updated
22 Jan 2014
Data monitoring committee
Yes

Publications

  • Zeuzem S, DeMasi R, Baldini A, Coate B, Luo D, Mrus J, Witek J. Risk factors predictive of anemia development during telaprevir plus peginterferon/ribavirin therapy in treatment-experienced patients. J Hepatol. 2014 Jun;60(6):1112-7. doi: 10.1016/j.jhep.2014.01.013. Epub 2014 Jan 29.

    PubMed 24486089

  • Younossi Z, Negro F, Serfaty L, Pol S, Diago M, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Focaccia R, Foster GR, Horban A, Lonjon-Domanec I, Coate B, DeMasi R, Picchio G, Witek J. Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology. 2013 Dec;58(6):1897-906. doi: 10.1002/hep.26437. Epub 2013 Oct 17.

    PubMed 24382638

  • Pol S, Aerssens J, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Younossi Z, Foster GR, Focaccia R, Horban A, Pockros PJ, Van Heeswijk RP, De Meyer S, Luo D, Botfield M, Beumont M, Picchio G. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure. J Hepatol. 2013 May;58(5):883-9. doi: 10.1016/j.jhep.2012.12.023. Epub 2013 Jan 12.

    PubMed 23321318

  • Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.

    PubMed 21696308

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telaprevir, Peg-IFN-alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Tibotec BVBA at 91 sites in 16 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 3 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, France, Australia, Germany, Israel and 11 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 11 Aug 2011). 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?

Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (time frame: Week 72). 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 NCT00703118, which also lists 4 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 22 Jan 2014.

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