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New triple therapy aims to clear hepatitis c before liver transplant

NCT ID NCT01463956

Disease control Sponsor: French National Agency for Research on AIDS and Viral Hepatitis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of three drugs (pegylated interferon, ribavirin, and boceprevir) in 58 adults with genotype 1 hepatitis C and cirrhosis who were waiting for a liver transplant. The goal was to see if the treatment could clear the virus before surgery. The study measured how many patients had no detectable virus six months after stopping treatment or at the time of transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

58 people

The number who actually took part.

Start date

Jan 2012

Finished

Jan 2015

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 * Inclusion approved by the Decision Support Committee Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

chronic hepatitis C virus infection cirrhosis of liver hepatitis C induced liver cirrhosis hepatitis C virus infection Liver Cirrhosis, Experimental

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HCV infection Liver cirrhosis, experimental

Contacts and locations

Locations

  • A Michallon Hospital

    Grenoble, 38700, France

  • Archet Hospital

    Nice, 06202 cedex 3, France

  • Beaujon Hospital

    Clichy, 92110, France

  • Civil Hospital

    Strasbourg, 67091 Cedex, France

  • Claude Huriez hospital

    Lille, 59037 cedex, France

  • Cochin Hospital

    Paris, 75014, France

  • Haut-Lévêque Hospital

    Bordeaux, 33601, France

  • Henri Mondor Hospital

    Créteil, 94010 Cedex, France

  • La Conception Hospital

    Marseille, 13285, France

  • La Croix-Rousse

    Lyon, 69 317 CEDEX, France

  • La Pitié Salpétrière Hospital

    Paris, 75013, France

  • Nancy Hospital

    Vandœuvre-lès-Nancy, 54500, France

  • Paul Brousse Hospital

    Villejuif, 94804 cedex, France

  • Pontchaillou Hospital

    Rennes, 35033 cedex 9, France

  • Purpan Hospital

    Toulouse, 31059 cedex, France

  • Purpan Hospital Médecine interne

    Toulouse, 31059 cedex, France

  • Saint-Eloi Hospital

    Montpellier, 34090, France

  • Staint Antoine Hospital

    Paris, 75571 Cedex 12, France

  • Trousseau Hospital

    Tours, 37044, France

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