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HCV InfectionPhase 2NCT01463956

Efficacy of PegInterferon-Ribavirin-Boceprevir Therapy in Patients Infected With G1 HCV With Cirrhosis, Awaiting Liver Transplantation

A Phase 2 study testing Boceprevir, Peg-Interferon α-2b or Peg-Interferon α-2a and Ribavirin in people with HCV Infection and Liver Cirrhosis, Experimental, run by French National Agency for Research on AIDS and Viral Hepatitis at 19 sites in France.

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

Evaluation of efficacy of triple therapy with pegylated interferon, ribavirin, and boceprevir in patients with genotype 1 chronic hepatitis C, who are treatment-naive, have relapsed, or are non-responders with cirrhosis and awaiting liver transplantation, with a MELD score less than or equal to 18 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HCV Infection, Liver Cirrhosis, Experimental
What is being tested?
Boceprevir, Peg-Interferon α-2b or Peg-Interferon α-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
19 sitesFrance
Study dates
6 Jan 2012to 22 Jan 2015
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult 18 years and older
  • Chronic infection with hepatitis C virus proven with positive PCR for more than 6 months
  • Viral genotype 1
  • Cirrhosis while awaiting liver transplantation
  • MELD score < or equal to 18
  • With or without hepatocellular carcinoma
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  • Naive to antiviral C treatment
  • Failure on a previous treatment. Failure is defined as the persistence of detectable HCV RNA. The previous HCV failure treatment profile must be able to be documented according to the following terminology:- Relapsing patient: HCV RNA undetectable at the end of treatment, becoming detectable again after the discontinuation of treatment- Breakthrough: increase of viremia of 1 log or more during the treatment - Non-responding patient with partial response: HCV RNA detectable at W24 without ever having been undetectable and with a decrease in HCV RNA ≥ 2 log at W12 - Non-responding patient with nul response: decrease in HCV RNA < 2 log at W12
  • No need for prior treatment wash-out
  • Negative pregnancy test in women of child-bearing age
  • Double method of contraception in men and women of child-bearing age during the entire duration of treatment and the 6 months following its discontinuation
  • Free, informed, and written consent (signed on the day of pre-enrollment at the latest and before all exams required by the study)
  • Person enrolled in or a beneficiary of a social security/Universal Health Insurance Coverage

Who cannot join

  • Previous HCV treatment with boceprevir or telaprevir
  • Alcohol consumption > 40 g/day
  • Toxicomania constituting a barrier for starting therapy according to the opinion of the investigator. Patients included in a methadone or buprenorphine replacement program may be enrolled
  • MELD > 18
  • Non controlled sepsis
  • Platelets < 50,000/mm3
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  • Neutrophil granulocyte levels < 1000/mm3
  • Creatinine clearance < 50 mL/min (MDRD)
  • Hb < 10 g/dL
  • Uncontrolled psychiatric problems
  • Contraindications to boceprevir
  • Contraindication to interferon or ribavirin
  • Subject with major complications of cirrhosis
  • HIV coinfection
  • HBV coinfection (unless this is treated effectively with analogues, as proven by undetectable viremia for at least 12 months)
  • Other infectious disease underway
  • Neoplastic disease other than hepatocellular carcinoma during the previous year, or neoplastic disease for which the prognosis is less than 3 years
  • Treatment with immunosuppressors (including corticosteroids), antivirals other than those for the study, except aciclovir
  • Consumption of St. John's wort
  • Associated treatments including a molecule or substance that could interfere with the pharmacokinetic characteristics of boceprevir
  • History of a lactose allergy
  • Person participating in another study including an exclusion period that is still underway during pre-enrollment
  • So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
  • Pregnancy, breast-feeding

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • Haut-Lévêque Hospital

    Bordeaux, 33601

  • Beaujon Hospital

    Clichy, 92110

  • Henri Mondor Hospital

    Créteil, 94010 Cedex

  • A Michallon Hospital

    Grenoble, 38700

  • Claude Huriez hospital

    Lille, 59037 cedex

  • La Croix-Rousse

    Lyon, 69 317 CEDEX

  • La Conception Hospital

    Marseille, 13285

  • Saint-Eloi Hospital

    Montpellier, 34090

  • Archet Hospital

    Nice, 06202 cedex 3

  • La Pitié Salpétrière Hospital

    Paris, 75013

  • Cochin Hospital

    Paris, 75014

  • Staint Antoine Hospital

    Paris, 75571 Cedex 12

  • Pontchaillou Hospital

    Rennes, 35033 cedex 9

  • Civil Hospital

    Strasbourg, 67091 Cedex

  • Purpan Hospital Médecine interne

    Toulouse, 31059 cedex

  • Purpan Hospital

    Toulouse, 31059 cedex

  • Trousseau Hospital

    Tours, 37044

  • Nancy Hospital

    Vandœuvre-lès-Nancy, 54500

  • Paul Brousse Hospital

    Villejuif, 94804 cedex

Other trials in France

About this study

Official title: Pilot Study on the Efficacy of Pegylated Interferon-Ribavirin-Boceprevir Triple Therapy in Patients Infected With Genotype 1 HCV With Cirrhosis and Awaiting Liver Transplantation (ANRS HC 29 BOCEPRETRANSPLANT)

Evaluation of efficacy of triple therapy with pegylated interferon, ribavirin, and boceprevir in patients with genotype 1 chronic hepatitis C, who are treatment-naive, have relapsed, or are non-responders with cirrhosis and awaiting liver transplantation, with a MELD score less than or equal to 18

Read the detailed description

Evaluation of sustained virological response defined as the proportion of patients with undetectable hepatitis C virus RNA 24 weeks after discontinuation of therapy and/or after liver transplantation in patients with genotype 1, who are treatment-naive, have relapsed, or are non-responders with cirrhosis and awaiting liver transplantation, with a MELD score less than or equal to 18

Being tested
Boceprevir, Peg-Interferon α-2b or Peg-Interferon α-2a, Ribavirin
Keywords
Boceprevir, HCV infection, Antiviral therapy, Liver transplantation
Medical subject headings
Hepatitis C, Liver Cirrhosis, Experimental

What participants receive

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

  • BoceprevirDrug

    Boceprevir 200 mg capsules at 2400mg/day (800mg 3 times a day) from week 4 until week 48 or until liver transplant (can be performed from week 16)

  • Peg-Interferon α-2b or Peg-Interferon α-2aBiological

    Also called PegIntron, PEG

    Peg-Interferon α-2b by subcutaneous injection, 1.5µg/kg/week, from day 0 until week 48 or until liver transplantation, or Peg-Interferon α-2a by subcutaneous injection, 180 µg, once weekly, from day 0 until week 48 or until liver transplantation

  • RibavirinDrug

    Ribavirin: capsules 200 mg (weight-based daily dose: <65kg, 800 mg; 65-80kg, 1000mg; 81-105kg: 1200mg; >105kg: 1400mg), from day 0 until week 48 or until liver transplantation or, Ribavirin: Tablet Oral, weight-based dose, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over75 kg, once daily, from day 0 until week 48 or until liver transplantation

Study groups in NCT01463956
Study groupRoleWhat they receive
Boceprevir, Pegylated interferon and RibavirinExperimental* Lead-in phase (4 week): Pegylated interferon + Ribavirin * Triple therapy regimen for 44 weeks :Boceprevir + Pegylated interferon + Ribavirin * Pegylated interferon + Ribavirin therapy until transplantation (less or equal to 24 weeks)
Receives: Drug: Boceprevir; Biological: Peg-Interferon α-2b or Peg-Interferon α-2a; Drug: Ribavirin

What is being measured

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

  1. Sustained Virologic Response (SVR) Rate

    Evaluation of sustained virologic response to antiviral C treatment depends of time of liver transplantation that can be performed between week 16 and week 96 of the trial:

    • If the liver transplant is realized after the discontinuation of antiviral C treatment,sustained virologic response should be evaluated 6 months after the discontinuation of antiviral C treatment and at the time of liver transplantation.
    • If the liver transplant is realized before the discontinuation of antiviral C treatment,sustained virologic response should be evaluated at the time of liver transplantation.

    Measured: Week 24 after the discontinuation of antiviral C treatment and at the time of liver transplantation or at the time of liver transplantation

Secondary outcomes (25)

  1. Number of participants with adverse events as a measure of safety and tolerability

    Information on adverse events will be collected by the investigator during medical visits and reported in the CRF. Adverse events will be classified as: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms

    Measured: From week 0 to week 144

  2. Perceived symptoms

    Information on symptoms as perceived by the patients will be collected through self-administered questionnaires.

    Measured: at day 0, week 24, week 48 and every 24 week up liver transplant - post liver transplant: day 0, week 24 and week 48

  3. Compliance rate.

    Treatment compliance will be assesses through a self-administered questionnaire reporting the number of medication doses prescribed and taken by the participants

    Measured: week 12, week 24, week 36, week 48, week 72 - after Liver transplant:Day 0

  4. SVR prognosis factors

    Participants with undetectable plasma HCV-RNA 24 weeks after treatment cessation and/or liver transplantation will be considered as SVR. Factors potentially associated with SVR will be studied through a logistic regression analysis. These factors include demographical (age, gender), virological (baseline viral load), clinical (disease severity measured by MELD score) and genetic factors (IL28B polymorphism: TT, CT, or CC)

    Measured: Week-4 up week 144

  5. The predictive value of on-treatment HCV RNA on SVR

    Quantitative assessment of HCV RNA during treatment will be performed at weeks 1, 4, 5, 6, 7, 8, 12, 16, 20, and 24 and correlated to SVR

    Measured: During weeks 1, 4, 5, 6, 7, 8, 12, 16, 20, and 24 (before transplantation)

  6. The percentage of virologic failure

    Virological failure is defined as an increase of HCV RNA of at least 1 log IU/mL during treatment, or by the reappearance of positive viremia during treatment, after an initial negative result

    Measured: week 4 and week 48

  7. The percentage of relapse after transplantation

    Virological relapse is characterized by an HCV RNA negative at the end of treatment but becoming detectable after cessation of therapy. The proportion of patients with virological relapse will be determined

    Measured: Between week 16 and week 144

  8. Boceprevir resistant mutations

    The proportion of patients with emergence of resistant mutations to boceprevir in case of detectable viral load during treatment (from W5) and after the discontinuation of treatment in the event of virologic failure will be assessed

    Measured: From week 5 to week 48 or after week 48

  9. Resistant mutations in plasma and liver samples (both explanted liver and graft)

    Measured: Week 16 up to week 96

  10. Sepsis according to Systemic Inflammatory Response System (SIRS) Criteria

    Measured: From day 0 to week 72

  11. Cirrhosis impairment

    Cirrhosis impairment will be assessed by studying:

    • the mean variation of MELD score between baseline and end of therapy
    • the proportion of patients with a MELD score increased by at least 3 points (in case of baseline MELD>15) or 5 points (in case of baseline MELD<15)

    Measured: From day 0 to week 72

  12. Survival after transplantation

    Measured: Week 16 up to week 96

  13. Survival rate within one year after liver transplantation

    Measured: week 64 up to week 144

  14. The mean time elapsed between registration on the transplantation list and the date of transplantation

    Measured: Week16 up to week 96

  15. Measurement of the residual plasma concentration (Cres) of ribavirin

    Measured: at Week 4 and Week 8

  16. Area Under the Plasma Concentration Time Curve (AUC) From 0-8h of Boceprevir

    Measured: At week 16 and at week 24 and if the MELD score has changed by more than three points

  17. Maximum Plasma Concentration (Cmax) of Boceprevir

    Measured: At week 16 and at week 24 and if the MELD score has changed by more than three points

  18. Time of Maximum Plasma Concentration (Tmax) of Boceprevir

    Measured: At week 16 and at week 24 and if the MELD score has changed by more than three points

  19. Minimum Plasma Concentration (Cmin) of Boceprevir

    Measured: At week 16 and at week 24 and if the MELD score has changed by more than three points

  20. Correlation study between the presence of an elevated level of IP-10 during triple therapy and the absence of sustained virologic response

    Plasma aliquots will be performed in all patients of the trial at day 0 before liver transplant and day 0 post liver transplant to measure IP10. Evaluation will be performed at the end of the trial for all patients recruited. The association between IP-10 level and SVR will be assessed

    Measured: From week 4 to week 48

  21. Histological severity of HCV recurrence after liver transplantation

    Histological severity will be assessed by the METAVIR score at 1 month (if early recurrence), at 6 months, 1 year after transplantation in case of non-response/relapse before transplantation .

    Liver transplantation can be performed between week 16 and week 96

    Measured: At week 20 up to week 100, at week 40 up to week 120, at week 64 up to week 144

  22. Insulin Resistance (HOMA-IR)

    Measured: At baseline, week 48 and at the last follow-up visit

  23. Virological Response in participants with and without Insulin Resistance

    Measured: At week 4, 8, 16, 28 and 48 during therapy

  24. Relationship between the presence of a polymorphism in the IL28B gene (donor and recipient) and SVR

    Whole blood aliquots (DNA bank) will be performed at the Day 0 visit to measure IL28B polymorphism. Evaluation will be performed at the end of the trial for all patients recruited. The SVR rate will be compared between the different IL28B phenotypes (CC, CT and TT).

    Measured: After week 144

  25. Relationship between the presence of a polymorphism to the ITPA gene and the onset of hemolytic anemia

    Whole blood aliquots (DNA bank) will be performed at the Day 0 visit for ITPA gene measure. Evaluation will be performed at the end of the trial for all patients recruited. The proportion of patients with occurrence of hemolytic anemia will be compared according to the ITPA polymorphism

    Measured: After week 144

Timeline

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

  1. First posted2 Nov 2011 (estimated)
  2. Study start6 Jan 2012
  3. Primary completionJun 2014
  4. Study completion22 Jan 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01463956
Sponsor's protocol ID
ANRS HC 29 BOCEPRETRANSPLANT
Other IDs
2011-001089-17
Status last verified
Jan 2017
First submitted
14 Oct 2011
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Fontaine H, Maynard M, Bouix C, Carrieri MP, Botta-Fridlund D, D'Alteroche L, Conti F, Pageaux GP, Leroy V, Metivier S, Anty R, Durand F, Canva V, Vilotitch A, Lebray P, Alric L, Duvoux C, Petrov-Sanchez V, Beaulieux F, Wellems C, Paul C, Roque-Afonso AM, Roche B, Pradat P, Samuel D, Duclos-Vallee JC; BOCEPRETRANSPLANT study group. Efficacy and safety of boceprevir-based triple therapy in HCV cirrhotic patients awaiting liver transplantation (ANRS HC29 BOCEPRETRANSPLANT). Clin Res Hepatol Gastroenterol. 2017 Feb;41(1):56-65. doi: 10.1016/j.clinre.2016.06.006. Epub 2016 Aug 20.

    PubMed 27554134

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Boceprevir, Peg-Interferon α-2b or Peg-Interferon α-2a and Ribavirin in people with HCV Infection and Liver Cirrhosis, Experimental, run by French National Agency for Research on AIDS and Viral Hepatitis at 19 sites in France.

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 13 inclusion and 24 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Sustained Virologic Response (SVR) Rate (time frame: Week 24 after the discontinuation of antiviral C treatment and at the time of liver transplantation or at the time of liver transplantation). 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 NCT01463956, 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 7 Apr 2026.

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