Treatment of Recurrent Hepatitis C After Liver Transplant... | NCT00151580

Studies
Treatment of Recurrent Hepatitis C After Liver Transplantation

NCT00151580

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

May 21, 2012Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

Liver Transplantation
Hepatitis C

Interventions

Ribavirin
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2002

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 9, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2012

Last Update Posted Date

May 21, 2012Estimated

Name	Class
Ministry of Health, France	OTHER_GOV
ANRS, Emerging Infectious Diseases	OTHER_GOV

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Ribavirin maintenance treatment	Drug: Ribavirin
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ribavirin	Drug	18 months of oral ribavirin maintenance treatment	1

Measure	Description	Time Frame
Negative viral PCR		30 months

Measure	Description	Time Frame
Histological improvement		30 months
Biological hepatic markers		30 months
Quality of life

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
Hemoglobin ≥ 10 g/dl
Platelet count ≥ 50.000/mm3
Normal TSH value
Serum creatinine < 200µmol/l
Informed written consent

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karim Boudjema, MD, PhD	Rennes University Hospital	Principal Investigator
Yvon Calmus, MD	AP-HP Hôpital Cochin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Hépatologie - Hôpital Jean Minjoz		Besançon		25030	France
Service de Chirurgie Digestive - Groupe Hospitalier Pellerin-Tripode

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10342322	Background	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.
9625309	Background	Berenguer 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.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Type	Description	Link
PHRC/00-02
CIC0203/049