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Hepatitis C, ChronicPhase 2/3NCT00323804

Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.

A Phase 2/3 study testing Peginterferon alfa-2b and Ribavirin in people with Hepatitis C, Chronic and Liver Fibrosis, run by ANRS, Emerging Infectious Diseases at 45 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of fibrosis is currently under investigation in large multicenter trials. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic, Liver Fibrosis
What is being tested?
Peginterferon alfa-2b and Ribavirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
372 participants
Where
45 sitesin 2 countries
Study dates
May 2006to Mar 2013
Phase
Phase 2/3
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

  • Adults over 18
  • With a hepatitis C virus infection (HCV RNA and anti-HCV antibodies in serum)
  • Not responders to a previous antiviral treatment using the interferon plus ribavirin combination
  • With a wash-out of treatment for at least 6 months
  • With an active chronic hepatitis C and a Metavir fibrosis score ≥ 2
  • Serum ALT levels > upper limit of the laboratory on two occasions within 6 months before inclusion
Show all 10Show fewer
  • Accepting to undergo a liver biopsy at the end of the study
  • Negative pregnancy test for women
  • With a social security cover
  • Written informed consent

Who cannot join

  • History of hepatic complications
  • History of transplantation
  • History of severe seizures
  • History of severe psychiatric disorders
  • Drug addiction within the last 12 months
  • Associated condition susceptible to be responsible for liver fibrosis
Show all 24Show fewer
  • Hepatocellular carcinoma
  • Cardiovascular disease unstable under treatment
  • Uncontrolled diabetes
  • Retinopathy
  • Thyroid disease unstable under treatment
  • Epilepsy and/or central nervous system functional disorders
  • Autoimmune disease
  • Regular alcohol consumption
  • Pregnancy, breast-feeding or absence of contraception
  • Haemoglobin <12 g/dl
  • platelets <50000/mm3
  • Neutrophils < 1200/ mm3
  • Severe hepatocellular failure (prothrombin index lower than 60%)
  • Renal failure (creatinine clearance lower than 50 mL/Mn)
  • Associated immunosuppressive drugs, corticosteroids, antiviral drugs (other than study ones)
  • Treatment with drugs likely to have an effect on fibrosis
  • Anticonvulsants
  • Inability to tolerate interferon

Trial locations and contacts

45 sites in 2 countries.

45 sites in 2 countries

France40 sites

  • Service d'Hépatogastroentérologie et d'endoscopie digestive - CH du Pays d'Aix

    Aix-en-Provence, 13616

  • Hôpital Nord

    Amiens, 80054

  • Service d'Hépatogastroentérologie - Hôpital Nord

    Amiens, 80054

  • Service d'Hépatologie - Gastroentérologie - Cancérologie digestive - CHU Angers

    Angers, 49100

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95100

  • Service d'Hépatogastroentérologie - Hôpital Avicenne

    Bobigny, 93009

  • Service d' Hépatogastroentérologie - Hôpital Jean Verdier

    Bondy, 93143

  • Service d'Hépatogastroentérologie et d'Assistance nutritive - Hôpital Haut-Lévêque

    Bordeaux Pessac, 33604

  • CH Pierre OUDOT

    Bourgoin, 38317

  • Service d'Hépatogastroentérologie - Hôpital de la Cavale Blanche

    Brest, 29200

  • Service d'Hépatologie - Gastroentérologie - Nutrition -Hôpital de la Côte de Nacre

    Caen, 14000

  • Centre Hospitalier

    Châteauroux, 36000

  • Service d'Hépatogastroentérologie - CHU d'ESTAING

    Clermont-Ferrand, 63003

  • Service d'Hépatogastroentérologie - Hôpital Beaujon

    Clichy, 92110

  • Service d'Hépatogastroentérologie - CH Sud Francilien

    Corbeil-Essonnes, 91106

  • Service d'Hépatogastroentérologie - Hôpital du Bocage

    Dijon, 21079

  • Hôpital Nord

    Grenoble, 38043

  • Service d'Hépatogastroentérologie - CH La Roche sur Yon

    La Roche-sur-Yon, 85925

  • Service des Maladies du Foie et de l'appareil Digestif - Hôpital de Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Département d'Hépatogastroentérologie - CH Le Mans

    Le Mans, 72037

  • Service d'Hépatogastroentérologie - CHRU - Hôpital Claude Huriez

    Lille, 59000

  • Service d'Hépatogastroentérologie - Hotel de la Croix Rousse

    Lyon, 69004

  • Service d'Hépatogastroentérologie - Hôpital Saint Joseph

    Marseille, 13285

  • Service d'Hépatogastroentérologie - CH Montauban

    Montauban, 82000

  • Service d'Hépatogastroentérologie - CH Montélimar

    Montélimar, 26200

  • Service d'Hépatogastroentérologie - Hôpital Saint Eloi

    Montpellier, 34295

  • Service d'Hépatogastroentérologie - Hôtel Dieu

    Nantes, 44093

  • Hôpital de l'Archet

    Nice, 06202

  • Service d'Hépatogastroentérologie - Hôpital de la Source

    Orléans, 45067

  • Service d'Hépatogastroentérologie - Hôpital La Pitié Salpétrière

    Paris, 75013

  • Service d'Hépatogastroentérologie - Hôpital Tenon

    Paris, 75020

  • Service d'Hépatogastroentérologie - Hôpital Pontchaillou

    Rennes, 35033

  • Service d'Hépatogastroentérologie - CHU Rouen

    Rouen, 76031

  • Centre Hospitalier

    Saint-Quentin, 02321

  • Service d'Hépatogastroentérologie, Clinique médicale B - Hôpital Civil

    Strasbourg, 67000

  • Hôpital Purpan

    Toulouse, 31059

  • Service d'Hépatogastroentérologie - Hôpital Purpan

    Toulouse, 31059

  • Service d'Hépatogastroentérologie - Hôpital Trousseau

    Tours, 37044

  • Service d'Hépatogastroentérologie - Hôpital Brabois

    Vandœuvre-lès-Nancy, 54500

  • Hôpita Paul Brousse

    Villejuif, 94804

Other trials in France

Belgium5 sites

  • CHU Brugmann

    Brussels, 1020

  • Hôpital Bracops

    Brussels, 1070

  • Hôpital Erasme

    Brussels, 1070

  • Hôpital de Jolimont

    La Louvière, 7100

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

About this study

Official title: Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Interest of a Long-term (3 Years) Treatment With Peginterferon Alfa-2b and Ribavirin on Liver Fibrosis in Non-responder Chronic Hepatitis C Patients.

Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of fibrosis is currently under investigation in large multicenter trials. The aim of our study is to assess if peginterferon alpha2b plus ribavirin is more efficient than peginterferon alpha2b alone. 454 patients will be randomized between the 2 arms and the efficacy will be assessed, after 3 years of treatment, on Metavir liver fibrosis score improvement.

Read the detailed description

Up to 45% of patients with chronic hepatitis C do not respond to pegylated interferon/ribavirin combination therapy. These patients are prone to develop liver fibrosis leading to cirrhosis and its complications. Interferon has proven to be efficient in liver fibrosis treatment even in case of virological non response. Maintenance low dose pegylated interferon therapy is currently under investigation in large multicenter trials. The aim of our study is to assess wether peginterferon alpha 2 b (0.5 µg/kg/week) plus ribavirin (800-1200 mg according to body weight) is more efficient than peginterferon alpha 2 b alone in a long term 3 years treatment of liver fibrosis. 454 patients, non responders (VHC RNA positive after 24 weeks of treatment or absence of ≥ 2 log HCV RNA drop after 12 weeks of treatment) to a previous peginterferon/ribavirin antiviral treatment will be randomized between the 2 arms, with a double-blind masking of ribavirin. The efficacy will be assessed on Metavir liver fibrosis score improvement between pre and post therapeutic liver biopsy.

Being tested
Peginterferon alfa-2b, Ribavirin, Ribavirin-Placebo
Keywords
Maintenance therapy, Non-responder patients, Ribavirin/peginterferon combination therapy, Hepatitis C, Chronic
Medical subject headings
Hepatitis C, Chronic, Liver Cirrhosis

What participants receive

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

  • Peginterferon alfa-2bBiological

    PegIFN alfa 2b in addition to ribavirin or ribavirin-placebo, from day 0 to M36

  • RibavirinDrug

    Ribavirin in addition to PegIFN alfa 2b, from day 0 to M36

  • Ribavirin-PlaceboDrug

    Ribavirin-placebo in addition to PegIFN alfa 2b, from day 0 to M36

Study groups in NCT00323804
Study groupRoleWhat they receive
Randomised PegIFN alfa 2b + ribavirin (RBV) armExperimentalCombination of ribavirin capsules 200 mg, weight-based daily dose ( <75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36
Receives: Biological: Peginterferon alfa-2b; Drug: Ribavirin
Randomised PegIFN alfa 2b + ribavirin-placebo armPlacebo comparatorCombination of ribavirin-placebo capsules 200 mg, weight-based daily dose ( <75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36
Receives: Biological: Peginterferon alfa-2b; Drug: Ribavirin-Placebo

What is being measured

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

  1. Rate of patients with at least a one point improvement in Metavir fibrosis score between the inclusion and the end-of-study liver biopsies.

    Measured: Screen visit and M36

Secondary outcomes (9)

  1. Distribution of the Metavir scoring on the end-of-study biopsy

    Measured: M36

  2. Distribution of the Chevallier fibrosis score

    Measured: Screen visit and M36

  3. Evolution of the area of fibrosis between the inclusion and the end-of -study biopsies

    Measured: Screen visit and M36

  4. Fibrosis serum markers

    Measured: Screen, day0, M6, M12, M24, M36

  5. Liver elasticity before and after treatment

    Measured: Screen,M12, M24, M36

  6. Safety of treatment and quality of life

    Measured: day0, M6, M12, M24, M36

  7. Frequency of occurrence of hepatic complications and/or liver transplantations

    Measured: Day 0 to M36

  8. Evolution of the hepatitis C viral load

    Measured: Screen to M36

  9. Rate of patients with loss of detectable hepatitis C virus RNA

    Measured: Day 0 to M36

Timeline

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

  1. First posted10 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionFeb 2013
  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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323804
Sponsor's protocol ID
ANRS HC15 NRfi
Other IDs
2005-002937-11, 2005
Status last verified
Aug 2014
First submitted
9 May 2006
Last updated
4 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Peginterferon alfa-2b and Ribavirin in people with Hepatitis C, Chronic and Liver Fibrosis, run by ANRS, Emerging Infectious Diseases at 45 sites in 2 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 10 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 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France, Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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?

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?

Rate of patients with at least a one point improvement in Metavir fibrosis score between the inclusion and the end-of-study liver biopsies. (time frame: Screen visit and M36). 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 NCT00323804.

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 4 Sep 2014.

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