AzTrials
AzTrials

Genotype 1 Chronic Hepatitis CPhase 3NCT01241760

VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

A Phase 3 study testing Ribavirin, Telaprevir and Pegylated interferon alfa-2a in people with Genotype 1 Chronic Hepatitis C and Treatment Naive, run by Janssen Infectious Diseases BVBA at 99 sites in 13 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 evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Ribavirin, Telaprevir and Pegylated interferon alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
744 participants
Where
99 sitesin 13 countries
Study dates
Dec 2010to Nov 2012
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 has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
  • Patients should not have had any previous treatment for hepatitis C
  • Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
  • Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
  • A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Who cannot join

  • Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
  • Patient has a pre-existing psychiatric condition
  • Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
  • Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
  • Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).

Trial locations and contacts

99 sites in 13 countries.

99 sites in 13 countries

United States37 sites

  • Study site

    Allentown, Pennsylvania

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Bradenton, Florida

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Downers Grove, Illinois

  • Study site

    Durham, North Carolina

  • Study site

    Egg Harbor Twp, New Jersey

  • Study site

    Falls Church, Virginia

  • Study site

    Hershey, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    La Jolla, California

  • Study site

    Lebanon, New Hampshire

  • Study site

    Los Angeles, California

  • Study site

    Lutherville, Maryland

  • Study site

    Marietta, Georgia

  • Study site

    New Haven, Connecticut

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Providence, Rhode Island

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Fe, New Mexico

  • Study site

    Seattle, Washington

  • Study site

    Statesville, North Carolina

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

France9 sites

  • Study site

    Clichy

  • Study site

    Créteil

  • Study site

    Grenoble

  • Study site

    Lille

  • Study site

    Lyon

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Vandœuvre-lès-Nancy

  • Study site

    Villejuif

Other trials in France

Australia8 sites

  • Study site

    Adelaide

  • Study site

    Camperdown

  • Study site

    Clayton

  • Study site

    Darlinghurst

  • Study site

    Fitzroy

  • Study site

    Greenslopes

  • Study site

    Melbourne

  • Study site

    Perth

Other trials in Australia

Germany8 sites

  • Study site

    Berlin

  • Study site

    Bochum

  • Study site

    Essen

  • Study site

    Frankfurt

  • Study site

    Hamburg

  • Study site

    Kiel

  • Study site

    Mainz

  • Study site

    Regensburg

Other trials in Germany

Belgium6 sites

  • Study site

    Antwerp

  • Study site

    Brussels

  • Study site

    Genk

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Poland6 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Czeladź

  • Study site

    Kielce

  • Study site

    Krakow

  • Study site

    Warsaw

Other trials in Poland

Spain6 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Santander

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

United Kingdom5 sites

  • Study site

    Birmingham

  • Study site

    Edinburgh

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Manchester

Other trials in United Kingdom

Brazil4 sites

  • Study site

    Campinas

  • Study site

    Salvador

  • Study site

    Santo André

  • Study site

    São Paulo

Other trials in Brazil

Austria3 sites

  • Study site

    Graz

  • Study site

    Linz

  • Study site

    Vienna

Other trials in Austria

Mexico3 sites

  • Study site

    Mex Ctity

  • Study site

    México

  • Study site

    Monterrey

Other trials in Mexico

Sweden3 sites

  • Study site

    Gothenburg

  • Study site

    Malmö

  • Study site

    Stockholm

Other trials in Sweden

Ireland1 site

  • Study site

    Dublin

Other trials in Ireland

About this study

Official title: A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Read the detailed description

This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.

Being tested
Ribavirin, Telaprevir, Pegylated interferon alfa-2a
Keywords
Genotype 1 chronic hepatitis C, VX-950-C211, VX-950, IL28B, Telaprevir, Hepatitis C, BID, Q8h, SOC
Medical subject headings
Hepatitis C

What participants receive

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

  • RibavirinDrug

    Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4

  • TelaprevirDrug

    1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks

  • Pegylated interferon alfa-2aDrug

    180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4

  • TelaprevirDrug

    750 mg (2 oral tablets) every 8 hours for 12 weeks

Study groups in NCT01241760
Study groupRoleWhat they receive
001 T(q8h) / PRExperimentalTelaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Receives: Drug: Ribavirin; Drug: Pegylated interferon alfa-2a; Drug: Telaprevir
002 T(b.i.d.) / PRExperimentalTelaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Receives: Drug: Ribavirin; Drug: Telaprevir; Drug: Pegylated interferon alfa-2a

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 (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)

    The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).

    Measured: End of trial, 12 weeks after last planned dose

Secondary outcomes (6)

  1. Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)

    The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.

    Measured: End of trial, 24 weeks after last planned dose

  2. Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)

    The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).

    Measured: End of trial, 72 weeks after the start of study medication

  3. Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.

    The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.

    Measured: Baseline, Week 4 and Week 4+12.

  4. Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs

    The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.

    Measured: Week 4, 12, 24, 32, 40

  5. Percentage of Participants Who Relapsed During Follow-up Period

    The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).

    Measured: During Follow-Up (24 weeks after the last dose of study drug)

  6. Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)

    The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.

    Measured: End of trial, 12 weeks after the last planned dose

Timeline

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

  1. First posted16 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2012
  4. Study completionNov 2012

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
None (open label)
Enrolment
744 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01241760
Sponsor's protocol ID
CR013711
Other IDs
OPTIMIZE-HCV, VX-950-C211, 2010-021628-84
Status last verified
May 2014
First submitted
28 Oct 2010
Last updated
4 Jun 2014
Data monitoring committee
Yes

Publications

  • Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.

    PubMed 25653396

  • Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hezode C, Rizzetto M, Parana R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.

    PubMed 24316262

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ribavirin, Telaprevir and Pegylated interferon alfa-2a in people with Genotype 1 Chronic Hepatitis C and Treatment Naive, run by Janssen Infectious Diseases BVBA at 99 sites in 13 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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, France, Australia, Germany, Belgium and 8 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 4 Jun 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 (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned) (time frame: End of trial, 12 weeks after last planned dose). 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 NCT01241760, which also lists 2 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 4 Jun 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in