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Genotype 1 Chronic Hepatitis CPhase 3NCT01498068

Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C

A Phase 3 study testing Telaprevir, Pegylated-interferon-alfa-2a and Ribavirin in people with Genotype 1 Chronic Hepatitis C, run by Janssen-Cilag International NV at 5 sites in Russia.

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 determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Genotype 1 Chronic Hepatitis C
What is being tested?
Telaprevir, Pegylated-interferon-alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
5 sitesRussia
Study dates
Jan 2012to Mar 2013
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

  • Participant has genotype 1 chronic hepatitis C with HCV RNA level >1000 IU/mL
  • Participant is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C, or participant is treatment-experienced who did not achieve sustained virologic response (SVR) 24 weeks after at least 1 prior course of Peg-IFN/RBV therapy (null-responder, partial-responder or viral relapse)
  • Participant must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan > 2 years ago prior to screening
  • A female participant of childbearing potential and a nonvasectomized male participant 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 participant ) or 7 months (male participant) after the last dose of RBV

Who cannot join

  • Prior non-responder that is classified as a viral breakthrough participant
  • Participant is infected or co-infected with HCV of another genotype than genotype 1
  • Participant has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
  • Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
  • Participant has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Russia5 sites

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Smolensk

  • Study site

    Stavropol

Other trials in Russia

About this study

Official title: Open-Label, Bridging Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Treatment- Naïve and Treatment-Experienced Russian Subjects With Genotype 1 Chronic Hepatitis C

The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic hepatitis C.

Read the detailed description

This is an open-label (all persons know the study drug assignment), multicenter study in treatment-naïve (participant did not receive any previous treatment for the treatment of hepatitis C) and treatment-experienced (participant did receive previous treatment for hepatitis C) Russian participants with genotype 1 chronic hepatitis C. After a screening period of approximately 4 weeks, participants will be treated for 12 weeks with telaprevir 750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status, response to previous treatment and individual virologic response during treatment in this study. After the treatment period, there is a follow-up phase of at least 12 weeks.

Being tested
Telaprevir, Pegylated-interferon-alfa-2a, Ribavirin
Keywords
Genotype 1 chronic Hepatitis C, VX-950HPC3007, VX-950, Hepatitis C, Telaprevir, HCV
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 Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks

  • Pegylated-interferon-alfa-2aDrug

    Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks

  • RibavirinDrug

    Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is < 75kg) or 1200mg (if participant's weight is >= 75kg) per day for 24 or 48 weeks.

Study groups in NCT01498068
Study groupRoleWhat they receive
Treatment-naïveExperimentalTreatment naïve participants will receive telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual ontreatment virologic response in this study.
Receives: Drug: Telaprevir; Drug: Pegylated-interferon-alfa-2a; Drug: Ribavirin
Treatment-experiencedExperimentalTreatment-experienced participants received telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Receives: Drug: Telaprevir; Drug: Pegylated-interferon-alfa-2a; Drug: Ribavirin

What is being measured

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

  1. Number of Participants With Extended Rapid Virologic Response (eRVR)

    A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.

    Measured: Week 4 and Week 12

Secondary outcomes (5)

  1. Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

    Changes from baseline in log10 HCV RNA levels were calculated.

    Measured: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48

  2. Number of Participants With Rapid Virologic Response (RVR) at Week 4

    A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4

    Measured: Week 4

  3. Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48

    The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks.

    Measured: Weeks 8, 12, 24, 32, 40 and 48

  4. Number of Participants With Virologic Failure

    Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.

    Measured: Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40

  5. Number of Participants in Each Specific Category of Treatment Outcome

    Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =>25 IU/mL during follow-up period after previous HCV RNA<25 IU/mL at planned end of treatment(EOT)[Week 24 or Week 48] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase >1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA has previously become <25 IU/mL during treatment).Stopping rule defined as HCV RNA value >1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA <25 IU/mL at actual EOT and never HCV RNA =>25 IU/mL thereafter.

    Measured: From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)

Timeline

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

  1. First posted23 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionApr 2012
  4. Study completionMar 2013

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01498068
Sponsor's protocol ID
CR100676
Other IDs
VX-950HPC3007
Status last verified
Jan 2015
First submitted
6 Dec 2011
Last updated
30 Jan 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telaprevir, Pegylated-interferon-alfa-2a and Ribavirin in people with Genotype 1 Chronic Hepatitis C, run by Janssen-Cilag International NV at 5 sites in Russia.

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 4 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 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia. 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 30 Dec 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?

Number of Participants With Extended Rapid Virologic Response (eRVR) (time frame: Week 4 and Week 12). 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 NCT01498068.

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 30 Jan 2015.

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