Pegylated Interferon and Ribavirin in Hepatitis C Virus I... | NCT00383864

Studies
Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.

NCT00383864

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Oct 6, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Hepatitis C

Interventions

Pegylated interferon and ribavirin

Countries

Spain

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

Oct 2006

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

Jul 2001

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Oct 2, 2006

First Submission Date that Met QC Criteria

Oct 2, 2006

First Posted Date

Oct 4, 2006Estimated

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

Oct 5, 2006

Last Update Posted Date

Oct 6, 2006Estimated

Name	Class
Schering-Plough	INDUSTRY

Description Module

Brief Summary

The purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in patients with chronic hepatitis C after liver transplantation. The only approved drugs for treatment of hepatitis C are pegylated interferon and ribavirin.

Detailed Description

Hepatitis C recurrence after liver transplantation remains the main cause of graft loss after liver transplantation. Several strategies can be used to prevent or treat hepatitis C in the setting of liver transplantation. There are no controlled studies evaluating the efficacy and safety of antiviral treatment (using pegylated interferon and ribavirin) in liver transplant recipients. The main endpoint of this study was: 1) histological outcomes (effect of antiviral treatment on disease progression, i.e. liver fibrosis). The secondary endpoint were 1) Sustained virological response (persistent HCV-RNA clearance) and 2) Safety of pegylated interferon and ribavirin

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Pegylated interferon and ribavirin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop

Secondary Outcomes

Measure	Description	Time Frame
Sustained virological response (persistent HCV-RNA negativation)
Safety of antiviral therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic hepatitis C defined by liver biopsy and presence of HCV-RNA
More than 6 months from liver transplantation
Written inform consent

Exclusion Criteria:

Severe hepatitis C recurrence (F3-F4 fibrosis stage, cholestatic hepatitis)
Double liver-kidney transplantation
Leucopenia (2000) or thrombocytopenia (40.000)
Anemia (Hemoglobin lower than 10 g/dL)
Renal failure (creatinine > 2 mg/dL)
Autoimmune disease
All contraindications for interferon and ribavirin therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xavier Forns, MD	Liver Unit, Hospital Clinic, Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liver Unit, Hospital Clinic		Barcelona		08036	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17484872	Derived	Carrion JA, Navasa M, Garcia-Retortillo M, Garcia-Pagan JC, Crespo G, Bruguera M, Bosch J, Forns X. Efficacy of antiviral therapy on hepatitis C recurrence after liver transplantation: a randomized controlled study. Gastroenterology. 2007 May;132(5):1746-56. doi: 10.1053/j.gastro.2007.03.041. Epub 2007 Mar 24.

ID	Term
D006526	Hepatitis C
D008103	Liver Cirrhosis

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