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Hepatitis CPhase 2NCT00580801

An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection

A Phase 2 study testing Telaprevir, Pegylated-interferon-alfa-2a and Ribavirin in people with Hepatitis C, run by Tibotec BVBA.

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 evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C
What is being tested?
Telaprevir, Pegylated-interferon-alfa-2a and Ribavirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
No sites listed yet
Study dates
Jan 2008to Jan 2010
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

Inclusion Criteria: - Participant has chronic Genotype 4 Hepatitis C infection

  • Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level greater than 10,000 International unit per milliliter (IU/mL) at Screening
  • Participant never received treatment for HCV
  • Participant was to be in good health (besides HCV infection), in the opinion of the Investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram [ECG]), with any chronic medical conditions under stable medical control
  • Participant had to be willing to refrain from the concomitant use of any medications or substances Exclusion Criteria: - Participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the Investigator's opinion would compromise the participant's safety and/or compliance with study procedures
  • Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
  • Female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
  • Participant has hypersensitivity to tartrazine
  • Participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months

About this study

Official title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection

The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.

Read the detailed description

This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4. The study consists of 4 parts: Screening period (6-week); Investigational Treatment period (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo); Standard Treatment period (consists of 46 or 48-week standard treatment); and Follow-up period (24-week). The activity of telaprevir will be evaluated by early viral kinetic parameters along with viral response and pharmacokinetic assessments during the investigational treatment phase. Participants' safety will be monitored throughout the study.

Conditions
Hepatitis C
Being tested
Telaprevir, Pegylated-interferon-alfa-2a, Placebo, Ribavirin
Keywords
Hepatitis C, Telaprevir, Pegylated-interferon-alfa-2a, Pegasys, Ribavirin, Copegus
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

    Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.

  • Pegylated-interferon-alfa-2aDrug

    Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.

  • PlaceboDrug

    Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.

  • RibavirinDrug

    Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.

Study groups in NCT00580801
Study groupRoleWhat they receive
Telaprevir and then Pegylated-interferon-alfa-2a+RibavirinExperimentalTelaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 2 to 50.
Receives: Drug: Telaprevir; Drug: Pegylated-interferon-alfa-2a; Drug: Ribavirin
Telaprevir+Pegylated-interferon-alfa-2a+RibavirinExperimentalTelaprevir 750 mg tablet will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48.
Receives: Drug: Telaprevir; Drug: Pegylated-interferon-alfa-2a; Drug: Ribavirin
Placebo+Pegylated-interferon-alfa-2a+RibavirinActive comparatorMatching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa 2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48.
Receives: Drug: Pegylated-interferon-alfa-2a; Drug: Placebo; Drug: Ribavirin

What is being measured

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

  1. Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15

    The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification [LLOQ=25 IU/mL] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.

    Measured: Baseline and Day 15

Secondary outcomes (11)

  1. Percentage of Participants With Viral Response (Undetectable HCV RNA)

    Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.

    Measured: Day 15 up to EOT (Week 48/50 or early discontinuation)

  2. Median Time to First Viral Response (Undetectable HCV RNA)

    Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.

    Measured: Up to Week 48/50

  3. Number of Participants With Viral Breakthrough (Detectable HCV RNA)

    Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.

    Measured: Day 8, Day 12, Day 15, Week 24/26 and Week 36/38

  4. Percentage of Participants With Sustained Viral Response (SVR)

    Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.

    Measured: Week 12 and 24 after the last dose of study medication

  5. Percentage of Participants With Relapse

    Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.

    Measured: Week 24 after EOT (Week 48/50 or early discontinuation)

  6. Area Under the Serum Concentration-Time Curve (AUC)

    The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15

  7. Maximum Serum Concentration (Cmax) of Telaprevir

    The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15

  8. Pre-Dose Serum Concentration (C[0h]) of Telaprevir

    The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).

    Measured: 0 hour (pre-dose) at Day 15

  9. Minimum Serum Concentration (Cmin) of Telaprevir on Day 15

    The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here.

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15

  10. Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir

    The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test).

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15

  11. Average Steady-State Serum Concentration (Css,av) of Telaprevir

    The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).

    Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15

Timeline

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

  1. First posted27 Dec 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionJan 2010
  4. Study completionJan 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00580801
Sponsor's protocol ID
CR013714
Other IDs
VX-950-TiDP24-C210
Status last verified
Aug 2013
First submitted
20 Dec 2007
Last updated
9 Sep 2013
Data monitoring committee
No

Publications

  • De Meyer S, Ghys A, Dierynck I, Beumont M, Luo D, Picchio G. Virologic characterization of genotype 4 hepatitis C virus variants in patients treated with telaprevir. Virol J. 2014 May 16;11:93. doi: 10.1186/1743-422X-11-93.

    PubMed 24886541

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telaprevir, Pegylated-interferon-alfa-2a and Ribavirin in people with Hepatitis C, run by Tibotec BVBA.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

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 12 Jul 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?

Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 (time frame: Baseline and Day 15). 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 NCT00580801, 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 9 Sep 2013.

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