Liver TransplantationPhase 3TRANSPEGNCT00151580
Treatment of Recurrent Hepatitis C After Liver Transplantation
A Phase 3 study testing Ribavirin in people with Liver Transplantation and Hepatitis C, run by Rennes University Hospital at 16 sites in France.
Trial summary
In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation. This recurrence usually causes chronic liver disease, in 50 to 80% of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Hepatitis C
- What is being tested?
- Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 16 sitesFrance
- Study dates
- Feb 2002to Jul 2006
- Phase
- Phase 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
- First liver transplantation or retransplantation in the month after initial transplantation
- Patients aged over 18 years
- Post-hepatitis C cirrhosis
- Equilibrated immunosuppressive treatment
- Positive PCR for hepatitis C virus
- Liver biopsy between 6 months and 5 years after the transplantation with a fibrosis Metavir score at least F1
Show all 11Show fewer
- Hemoglobin ≥ 10 g/dl
- Platelet count ≥ 50.000/mm3
- Normal TSH value
- Serum creatinine < 200µmol/l
- Informed written consent
Who cannot join
- Chronic rejection
- Acute rejection at inclusion
- Multi-visceral transplantation
- Renal or cardiac failure, severe sepsis
- Uncontrolled diabetes
- Positive serology for hepatitis B or HIV at inclusion
Show all 14Show fewer
- EBV virus replication at inclusion
- Hepatocellular carcinoma at inclusion
- Cirrhosis with a fibrosis Metavir score F4 at inclusion
- Inclusion in another clinical trial less than one month ago
- Pregnancy
- Contra-indication to ribavirin or interferon
- History of or current psychiatric troubles
- Thyroid disease uncontrolled by treatment
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Service d'Hépatologie - Hôpital Jean Minjoz
Besançon, 25030
Service de Chirurgie Digestive - Groupe Hospitalier Pellerin-Tripode
Bordeaux, 33000
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, 92110
Service d'Hépatologie et Gastroentérologie - Hôpital Henri Mondor
Créteil, 94010
Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez
Lille, 59037
Médecine Digestive - Hôtel Dieu
Lyon, 69288
Service de Chirurgie Générale - Hôpital Edouard Herriot
Lyon, 69437
Chirurgie Générale - Hôpital de la Conception
Marseille, 13385
Service d'Hépaogastroentérologie - Hôpital Saint Eloi
Montpellier
Chirurgie Viscérale et Digestive -Hôpital de l'Archet
Nice, 06202
Service Hépato-gastroentérologie - Hôpital Saint Antoine
Paris, 75571
Service de Chirurgie Générale et Digestive - Hôpital Cochin
Paris, 75679
Département de Chirurgie Viscérale- Hôpital Pontchaillou
Rennes, 35033
Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
Strasbourg, 67098
Hôpital de Rangueil
Toulouse, 31403
Centre Hépato-biliaire - Hôpital Paul Brousse
Villejuif
About this study
Official title: Comparison of Maintenance Treatment by Ribavirin to a Placebo, After an Initial One-year Treatment With Pegylated Interferon-α2a - Ribavirin Association in Hepatitis C Viral Recurrence After Liver Transplantation
In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation. This recurrence usually causes chronic liver disease, in 50 to 80% of the patients. The interest of a long-term treatment with ribavirin alone after transplantation has not been clearly demonstrated. The objective of our study is to evaluate the efficacy of ribavirin as a maintenance treatment after a one year interferon-α / ribavirin therapy on hepatitis C recurrence in the transplanted liver.
Read the detailed description
Several therapeutic patterns have been described for the treatment of hepatitis C post-transplantation recurrence. A combination treatment associating interferon-α and ribavirin has shown some efficacy, but this efficacy has not been assessed yet in a placebo-controlled double-blind clinical trial. In our study, all included transplanted patients will be treated during 1 year with interferon-α and ribavirin. At the end of this period, they will be randomized to receive a maintenance treatment with ribavirin or a placebo for 1 additional year. Efficacy will be assessed on virological response after 30 months of treatment.
- Conditions
- Liver Transplantation, Hepatitis C
- Being tested
- Ribavirin, Placebo
- Keywords
- Hepatitis C, Viral recurrence, Ribavirin / Interferon
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
18 months of oral ribavirin maintenance treatment
PlaceboDrug
18 months oral placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ribavirin maintenance treatment Receives: Drug: Ribavirin |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative viral PCR
Measured: 30 months
Secondary outcomes (8)
Histological improvement
Measured: 30 months
Biological hepatic markers
Measured: 30 months
Quality of life
Measured: 30 months
Intensity, severity and delay to acute transplant rejection, histologically proven
Measured: 30 months
Incidence of death or graft loss
Measured: 30 months
Number of patients stopping the treatment and causes
Measured: 30 months
Incidence of adverse events classically related to treatment
Measured: 30 months
Incidence of adverse events possibly related to treatment
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startFeb 2002
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, ANRS, Emerging Infectious Diseases
- Investigators
- Karim Boudjema, MD, PhD, Principal investigator, Rennes University HospitalYvon Calmus, MD, Principal investigator, AP-HP Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151580
- Sponsor's protocol ID
- AFSSAPS 010588
- Other IDs
- PHRC/00-02, CIC0203/049
- Acronym
- TRANSPEG
- Status last verified
- Nov 2007
- First submitted
- 8 Sep 2005
- Last updated
- 21 May 2012
- Results posted
- No
Publications
Cattral MS, Hemming AW, Wanless IR, Al Ashgar H, Krajden M, Lilly L, Greig PD, Levy GA. Outcome of long-term ribavirin therapy for recurrent hepatitis C after liver transplantation. Transplantation. 1999 May 15;67(9):1277-80. doi: 10.1097/00007890-199905150-00014.
PubMed 10342322Berenguer M, Prieto M, Cordoba J, Rayon JM, Carrasco D, Olaso V, San-Juan F, Gobernado M, Mir J, Berenguer J. Early development of chronic active hepatitis in recurrent hepatitis C virus infection after liver transplantation: association with treatment of rejection. J Hepatol. 1998 May;28(5):756-63. doi: 10.1016/s0168-8278(98)80224-9.
PubMed 9625309
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maintenance Treatment by Ribavirin to a Placebo, After an Initial One-year Treatment With Pegylated Interferon-α2a - Ribavirin Association in Hepatitis C Viral Recurrence After Liver Transplantation
- ClinicalTrials.gov ID
- NCT00151580
- Acronym / sponsor ID
- TRANSPEG / AFSSAPS 010588
- Conditions
- Liver Transplantation, Hepatitis C
- Keywords
- Hepatitis C, Viral recurrence, Ribavirin / Interferon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France, ANRS, Emerging Infectious Diseases
- Study start
- Feb 2002
- Study completion
- Jul 2006 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation. This recurrence usually causes chronic liver disease, in 50 to 80% of the patients. The interest of a long-term treatment with ribavirin alone after transplantation has not been clearly demonstrated. The objective of our study is to evaluate the efficacy of ribavirin as a maintenance treatment after a one year interferon-α / ribavirin therapy on hepatitis C recurrence in the transplanted liver.
Detailed description
Several therapeutic patterns have been described for the treatment of hepatitis C post-transplantation recurrence. A combination treatment associating interferon-α and ribavirin has shown some efficacy, but this efficacy has not been assessed yet in a placebo-controlled double-blind clinical trial. In our study, all included transplanted patients will be treated during 1 year with interferon-α and ribavirin. At the end of this period, they will be randomized to receive a maintenance treatment with ribavirin or a placebo for 1 additional year. Efficacy will be assessed on virological response after 30 months of treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RibavirinRibavirin maintenance treatment |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- First liver transplantation or retransplantation in the month after initial transplantation
- Patients aged over 18 years
- Post-hepatitis C cirrhosis
- Equilibrated immunosuppressive treatment
- Positive PCR for hepatitis C virus
Key exclusion criteria (14 listed)
- Chronic rejection
- Acute rejection at inclusion
- Multi-visceral transplantation
- Renal or cardiac failure, severe sepsis
- Uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ribavirin18 months of oral ribavirin maintenance treatment | Drug | 1 |
| Placebo18 months oral placebo treatment | Drug | 2 |
Primary outcome
Negative viral PCR
Time frame: 30 months
8 secondary outcomes
Histological improvement
Time frame: 30 months
Biological hepatic markers
Time frame: 30 months
Quality of life
Time frame: 30 months
Intensity, severity and delay to acute transplant rejection, histologically proven
Time frame: 30 months
Incidence of death or graft loss
Time frame: 30 months
Number of patients stopping the treatment and causes
Time frame: 30 months
Incidence of adverse events classically related to treatment
Time frame: 30 months
Incidence of adverse events possibly related to treatment
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
- Background: PubMed 10342322Cattral MS, Hemming AW, Wanless IR, Al Ashgar H, Krajden M, Lilly L, Greig PD, Levy GA. Outcome of long-term ribavirin therapy for recurrent hepatitis C after liver transplantation. Transplantation. 1999 May 15;67(9):1277-80. doi: 10.1097/00007890-199905150-00014.
- Background: PubMed 9625309Berenguer M, Prieto M, Cordoba J, Rayon JM, Carrasco D, Olaso V, San-Juan F, Gobernado M, Mir J, Berenguer J. Early development of chronic active hepatitis in recurrent hepatitis C virus infection after liver transplantation: association with treatment of rejection. J Hepatol. 1998 May;28(5):756-63. doi: 10.1016/s0168-8278(98)80224-9.
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Boudjema, MD, PhD principal investigator
Rennes University Hospital
Yvon Calmus, MD principal investigator
AP-HP Hôpital Cochin
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ribavirin in people with Liver Transplantation and Hepatitis C, run by Rennes University Hospital at 16 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 11 inclusion and 14 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 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. 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 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?
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?
Negative viral PCR (time frame: 30 months). 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 NCT00151580, which also lists 2 linked publications.
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 21 May 2012.