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Hepatitis CPhase 3NCT00758043

A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

A Phase 3 study testing telaprevir, ribavirin and peginterferon alfa-2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 82 sites in 4 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

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). 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?
telaprevir, ribavirin and peginterferon alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
82 sitesin 4 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

  • Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
  • Male and female subjects, 18 to 70 years of age, inclusive
  • Genotype 1, chronic hepatitis C with detectable HCV RNA.
  • Screening laboratory values, tests, and physical exam within acceptable ranges
  • Able and willing to follow contraception requirements
  • Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.

Who cannot join

  • Subject has any contraindications to Pegasys® or Copegus® therapy
  • Evidence of hepatic decompensation in cirrhotic subjects
  • History of organ transplant
  • History of, or any current medical condition which could impact the safety of the subject in participation in the study

Trial locations and contacts

82 sites in 4 countries.

82 sites in 4 countries

United States74 sites

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Atlantic City, New Jersey, 08401

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Bayside, New York, 11358

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Cleveland, Ohio, 44109

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Dallas, Texas, 75203

  • Study site

    Dallas, Texas, 75246

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Downers Grove, Illinois, 60515

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Egg Harbor, New Jersey, 08234

  • Study site

    Falls Church, Virginia, 22042

  • Study site

    Farmington, Connecticut, 06030

  • Study site

    Fresno, California, 93721

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Honolulu, Hawaii, 96817

  • Study site

    Hyattsville, Maryland, 20783

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Kansas City, Missouri, 64131

  • Study site

    La Jolla, California, 92037

  • Study site

    Laurel, Maryland, 20707

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Los Angeles, California, 90048

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    Manhasset, New York, 11030

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami, Florida, 33136

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10029

  • Study site

    New York, New York, 10032

  • Study site

    Novi, Michigan, 48377

  • Study site

    Orlando, Florida, 32803

  • Study site

    Philadelphia, Pennsylvania, 19141

  • Study site

    Phoenix, Arizona, 85054

  • Study site

    Portland, Oregon, 97239

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Sacramento, California, 95817

  • Study site

    Salt Lake City, Utah, 84132

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Diego, California, 92115

  • Study site

    San Diego, California, 92123

  • Study site

    San Francisco, California, 94115

  • Study site

    San Francisco, California, 94143

  • Study site

    Sarasota, Florida, 34243

  • Study site

    Seattle, Washington, 98104

  • Study site

    St Louis, Missouri, 63104

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Statesville, North Carolina, 28677

  • Study site

    Tacoma, Washington, 98405

  • Study site

    The Bronx, New York, 10467

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Wellington, Florida, 33414

  • Study site

    Worcester, Massachusetts, 01655

Other trials in United States

Belgium4 sites

  • Study site

    Brussels, B1070

  • Study site

    Brussels, B1200

  • Study site

    Ghent, 9000

  • Study site

    Liège, 4000

Other trials in Belgium

Netherlands3 sites

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Amsterdam, 1100 DE

  • Study site

    Arnhem, 6815 AD

Other trials in Netherlands

Puerto Rico1 site

  • Study site

    Santurce, 00909

Other trials in Puerto Rico

About this study

Official title: A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

Conditions
Hepatitis C
Being tested
telaprevir, ribavirin, peginterferon alfa-2a
Keywords
Genotype 1
Medical subject headings
Hepatitis C

What participants receive

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

  • telaprevirDrug

    Also called VX-950

    750 mg every 8 hours (q8h) for 12 weeks

  • ribavirinDrug

    Also called Copegus

    1000 - 1200 mg/day based on body weight for either 24 or 48 weeks

  • peginterferon alfa-2aBiological

    Also called Pegasys

    180 mcg/week for either 24 or 48 weeks

Study groups in NCT00758043
Study groupRoleWhat they receive
T12PR24 (eRVR+)ExperimentalRandomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Receives: Drug: telaprevir; Drug: ribavirin; Biological: peginterferon alfa-2a
T12PR48 (eRVR+)ExperimentalRandomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Receives: Drug: telaprevir; Drug: ribavirin; Biological: peginterferon alfa-2a
T12PR48 (eRVR-)ExperimentalAssigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group
Receives: Drug: telaprevir; Drug: ribavirin; Biological: peginterferon alfa-2a
OtherExperimentalOther Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen.
Receives: Drug: telaprevir; Drug: ribavirin; Biological: peginterferon alfa-2a

What is being measured

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

  1. Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)

    SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).

    Measured: 24 weeks after the last planned dose of study treatment

Secondary outcomes (7)

  1. Proportion of Subjects Who Have Undetectable HCV RNA at Week 72

    SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.

    Measured: 72 weeks after the last planned dose of study treatment

  2. Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12

    Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).

    Measured: Week 4 and Week 12

  3. Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment

    SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.

    Measured: 12 weeks after last dose of study treatment

  4. Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)

    Measured: Week 24 or Week 48

  5. Proportion of Randomized Subjects Who Relapse

    Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT).

    Measured: From EOT to Week 48 or Week 72

  6. Proportion of Enrolled Subjects Who Relapse

    Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up.

    Measured: From EOT to Week 48 or Week 72

  7. Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Day 1 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 posted23 Sep 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJun 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
None (open label)
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00758043
Sponsor's protocol ID
VX08-950-111
Other IDs
EudraCT 2008-003836-39
Status last verified
Mar 2021
First submitted
19 Sep 2008
Last updated
26 Mar 2021
Data monitoring committee
Yes

Publications

  • Sherman KE, Flamm SL, Afdhal NH, Nelson DR, Sulkowski MS, Everson GT, Fried MW, Adler M, Reesink HW, Martin M, Sankoh AJ, Adda N, Kauffman RS, George S, Wright CI, Poordad F; ILLUMINATE Study Team. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011 Sep 15;365(11):1014-24. doi: 10.1056/NEJMoa1014463.

    PubMed 21916639

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing telaprevir, ribavirin and peginterferon alfa-2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 82 sites in 4 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 6 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 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Belgium, Netherlands, Puerto Rico. 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 21 Jul 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?

Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (time frame: 24 weeks after the last planned dose of study treatment). 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 NCT00758043, 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 Mar 2021.

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