Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-01 @ 4:37 AM
Study NCT ID:
NCT00375895
Status:
TERMINATED
Last Update Posted:
2012-03-02
First Post:
2006-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Switch From Tacrolimus to Cyclosporin in the Treatment of Recurrent Hepatitis C After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Insufficient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-01', 'studyFirstSubmitDate': '2006-09-12', 'studyFirstSubmitQcDate': '2006-09-12', 'lastUpdatePostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolonged virological response', 'timeFrame': '19 months', 'description': 'Percentage of patients with a negative qualitative PCR, 19 months after the initiation of cyclosporin treatment.'}], 'secondaryOutcomes': [{'measure': 'Virological response 4, 7 and 13 months after the initiation of cyclosporin treatment', 'timeFrame': '4, 7 and 13 months', 'description': 'Percentage of patient with negative or decreased quantitative PCR'}, {'measure': 'Histological response: METAVIR score at 19 months', 'timeFrame': '19 months'}, {'measure': 'Biological response: liver function at 4, 7, 13 and 19 months', 'timeFrame': '4, 7, 13 and 19 months', 'description': 'Transaminases, gammaGT, alcalin phosphatase, total bilirubin.'}, {'measure': 'Incidence of acute or chronic graft rejection at 19 months', 'timeFrame': '19 months'}, {'measure': 'Incidence of death, graft loss and retransplantation at 13 and 19 months', 'timeFrame': '13 and 19 months'}, {'measure': 'Renal function at 4, 7, 13 and 19 months', 'timeFrame': '4, 7, 13 and 19 months', 'description': 'Creatinin clearance'}, {'measure': 'Incidence of treatment discontinuation at 4, 7, 13 and 19 months', 'timeFrame': '4, 7, 13 and 19 months'}, {'measure': 'Incidence of adverse events (cancers in particular).', 'timeFrame': '19 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cyclosporin', 'Peginterferon', 'Ribavirin', 'Chronic hepatitis C', 'Liver transplantation'], 'conditions': ['Chronic Hepatitis C', 'Evidence of Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'In France, 50% of 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 and recurrence causes chronic liver disease in 50 to 80% of cases. The aim of this study is to assess the efficacy of cyclosporin on C virological response. Patients included in the Transpeg 1 study and non-responder or with a recurrent disease will be switched from their tacrolimus therapy to cyclosporin, in association with a 1 year peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment.', 'detailedDescription': 'In France, 50% of 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. A main factor determining the severity of recurrent hepatitis C after transplantation may be immunosuppression. Thus optimization of immunosuppressive regimens might be a key aspect to improve the prognosis of chronic hepatitis C in transplanted patients. The two most frequently used immunosuppressive drugs are cyclosporin and tacrolimus. However, it has been shown that virus replication could be inhibited by cyclosporin, through the blockade of cyclophilins, decreasing hepatitis C viral load and improving liver function. These effects were not found with tacrolimus.\n\nThe aim of our study is to assess the efficacy on C virological response of the switch from tacrolimus to cyclosporin associated with a peginterferon alfa-2a / ribavirin bitherapy, in non-responder or with a recurrent VHC+ disease liver transplanted patients.\n\nPatients will receive a 19 month cyclosporin treatment, associated during 12 months with a peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 or over,\n* Who had been included in the Transpeg 1 study,\n* Non-responders after a three month peginterferon alfa-2a / ribavirin bitherapy or with a recurrent disease during the Transpeg 1 maintenance phase, whatever the randomization group (ribavirin or placebo),\n* With a positive qualitative PCR at inclusion,\n* With a METAVIR histologic score of 1 or more on the last biopsy (done within the 6 months preceding inclusion),\n* Treated with tacrolimus for at least 6 months prior to inclusion,\n* Having given a written informed consent.\n\nExclusion Criteria:\n\n* Treatment with peginterferon or ribavirin within the 6 months preceding inclusion,\n* Severe hepatocellular failure or decompensated cirrhosis,\n* Acute graft rejection within the two months preceding inclusion, or signs of chronic rejection on the last biopsy, or retransplantation since inclusion in the Transpeg 1 study,\n* Treatment with cyclosporin for more than 6 months during the 24 months preceding inclusion,\n* Treatment with a mTOR inhibitor or with another investigational immunosuppressive drug,\n* Positive serology for HIV or HBV,\n* Cancer (or history of other malignancy during the last 5 years) except patients transplanted for hepatocellular carcinoma and basocellular or excised spinocellular carcinoma,\n* Serious concomitant disease or acute or chronic disorder, other than the current transplant, treated with steroids,\n* Serious cardiac pathology within the last 6 months,\n* Women with ongoing pregnancy or breast-feeding,\n* Serious chronic renal failure (creatinine clearance \\< 30 ml/mn),\n* Haemoglobin \\< 10 g/dl, platelets \\< 50 000/mm3 or neutrophils \\< 1000 / mm3,\n* Abnormal TSH values,\n* Inability to cooperate or to communicate with the investigator,\n* Contraindications to ribavirin, peginterferon alfa-2a or cyclosporin.'}, 'identificationModule': {'nctId': 'NCT00375895', 'briefTitle': 'Switch From Tacrolimus to Cyclosporin in the Treatment of Recurrent Hepatitis C After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Prospective, Open-label, Single Arm Pilot Study Evaluating the Effect on Virological Response of the Switch From Tacrolimus to Cyclosporin Associated With a Peginterferon Alfa-2a / Ribavirin Bitherapy, in Non-responder or With Recurrent VHC+ Disease Liver Transplanted Patients.', 'orgStudyIdInfo': {'id': 'EudraCT 2006-002714-35'}, 'secondaryIdInfos': [{'id': 'LOC/06-05', 'type': 'OTHER', 'domain': 'Rennes University Hospital'}, {'id': 'CIC0203/058'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ciclosporin', 'interventionNames': ['Drug: ciclosporin']}], 'interventions': [{'name': 'ciclosporin', 'type': 'DRUG', 'otherNames': ['CsA', 'Cyclosporin'], 'description': 'ciclosporin administered orally twice a day, at the initial dosing of 2.5 mg/kg/d, adjusted to obtain a C2 concentration of 600 ng/ml associated with the usual ribavirin and PEGinterferon bitherapy.', 'armGroupLabels': ['Ciclosporin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': "Service d'Hépatologie - Hôpital Jean Minjoz", 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '92118', 'city': 'Clichy', 'country': 'France', 'facility': "Service d'Hépatogastroentérologie - Hôpital Beaujon", 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': "Service d'Hépatologie et Gastroentérologie - CH Henri Mondor", 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': "Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Service de Chirurgie Générale - Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Chirurgie Générale - Hôpital de la Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': "Service d'Hépato-gastro-entérologie - Hôpital Saint Eloi", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': "Chirurgie Viscérale et Digestive - Hôpital de l'Archet", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Chirurgie Générale - Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Service des Maladies du Foie - Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31403', 'city': 'Toulouse', 'country': 'France', 'facility': "Service d'Hépato-gastro-entérologie - Hôpital de Rangueil", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94804', 'city': 'Villejuif', 'country': 'France', 'facility': 'Centre Hépato-Biliaire - Hôpital Paul Brousse', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Yvon Calmus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Cochin, Paris'}, {'name': 'Eric Bellissant, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Rennes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}