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Chronic Hepatitis CPhase 2NCT00528528

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

A Phase 2 study testing Telaprevir, Peg-IFN-alfa-2a and Peg-IFN-alfa-2b in people with Chronic Hepatitis C, run by Tibotec BVBA at 24 sites in 6 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 explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Telaprevir, Peg-IFN-alfa-2a and Peg-IFN-alfa-2b
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
24 sitesin 6 countries
Study dates
Oct 2007to Aug 2009
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic genotype 1 Hepatitis (inflammation of the liver) C infection
  • Never been treated for Hepatitis C Viral (HCV) infection
  • No clinically significant lab abnormalities
  • Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry
  • Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

Who cannot join

  • Contra-indications for starting anti-HCV therapy
  • History or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease
  • Any evidence of significant liver disease in addition to Hepatitis C
  • Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B
  • Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding

Trial locations and contacts

24 sites in 6 countries.

24 sites in 6 countries

France7 sites

  • Study site

    Angers

  • Study site

    Clichy

  • Study site

    Grenoble

  • Study site

    Lille

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Germany7 sites

  • Study site

    Cologne

  • Study site

    Düsseldorf

  • Study site

    Frankfurt

  • Study site

    Freiburg im Breisgau

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Tübingen

Other trials in Germany

Belgium4 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Spain3 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Valencia

Other trials in Spain

Netherlands2 sites

  • Study site

    Leiden

  • Study site

    Nijmegen

Other trials in Netherlands

Austria1 site

  • Study site

    Vienna

Other trials in Austria

About this study

Official title: A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

Read the detailed description

This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and participants will continue on standard therapy only. Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram [mg] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon [Peg-IFN]-alfa-2a and ribavirin [RBV] or Peg-IFN-alfa-2b and RBV at the standard doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety will be monitored throughout the study duration.

Being tested
Telaprevir, Peg-IFN-alfa-2a, Peg-IFN-alfa-2b, Ribavirin (RBV) tablet, Ribavirin (RBV) capsule
Keywords
Chronic Hepatitis C, Genotype 1, Telaprevir, Treatment-naïve, VX-950-C208, VX-950-TiDP24-C208
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

    Oval tablets containing 375 mg of telaprevir for oral administration.

  • Peg-IFN-alfa-2aDrug

    Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.

  • Peg-IFN-alfa-2bDrug

    Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.

  • Ribavirin (RBV) tabletDrug

    Tablets containing 200 mg RBV for oral administration.

  • Ribavirin (RBV) capsuleDrug

    Capsules containing 200 mg RBV for oral administration.

Study groups in NCT00528528
Study groupRoleWhat they receive
Telaprevir 750 mg with Peg-IFN-alfa-2a/RBV tabletExperimentalTelaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2a; Drug: Ribavirin (RBV) tablet
Telaprevir 750 mg with Peg-IFN-alfa-2b/RBV capsuleExperimentalTelaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2b; Drug: Ribavirin (RBV) capsule
Telaprevir 1125 mg with Peg-IFN-alfa-2a/RBV tabletExperimentalTelaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2a; Drug: Ribavirin (RBV) tablet
Telaprevir 1125 mg with Peg-IFN-alfa-2b/RBV capsuleExperimentalTelaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2b; Drug: Ribavirin (RBV) capsule

What is being measured

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

  1. Percentage of Participants With Virologic Response at Week 12

    Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).

    Measured: End of treatment (EOT) (up to Week 48)

Secondary outcomes (6)

  1. Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level

    Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).

    Measured: Baseline (Day 1) up to EOT (up to Week 48)

  2. Number of Participants With Viral Breakthrough at End of Treatment (EOT)

    Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.

    Measured: EOT (up to Week 48)

  3. Percentage of Participants With Partial Response

    Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples).

    Measured: Baseline (Day 1) up to EOT (up to Week 48)

  4. Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12

    Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.

    Measured: Baseline (pre-dose), Week 12

  5. Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)

    Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.

    Measured: Baseline (pre-dose), EOT (up to Week 48)

  6. Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)

    SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.

    Measured: EOT (up to Week 48) and up to 24 weeks after EOT

Timeline

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

  1. First posted12 Sep 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionJul 2009
  4. Study completionAug 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00528528
Sponsor's protocol ID
CR013516
Other IDs
VX-950-TIDP24-C208, 2007-001044-44
Status last verified
Jun 2014
First submitted
10 Sep 2007
Last updated
25 Jun 2014
Data monitoring committee
No

Publications

  • Serfaty L, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Lonjon-Domanec I, DeMasi R, Picchio G, Beumont M, Marcellin P. Insulin resistance and response to telaprevir plus peginterferon alpha and ribavirin in treatment-naive patients infected with HCV genotype 1. Gut. 2012 Oct;61(10):1473-80. doi: 10.1136/gutjnl-2011-300749. Epub 2012 Mar 2.

    PubMed 22387529

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telaprevir, Peg-IFN-alfa-2a and Peg-IFN-alfa-2b in people with Chronic Hepatitis C, run by Tibotec BVBA at 24 sites in 6 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 25 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 24 sites in France, Germany, Belgium, Spain, Netherlands and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 1 May 2013). 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 Virologic Response at Week 12 (time frame: End of treatment (EOT) (up to 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 NCT00528528, 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 25 Jun 2014.

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