NCT00383864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2006

Completed
Last Updated

October 6, 2006

Status Verified

October 1, 2006

First QC Date

October 2, 2006

Last Update Submit

October 5, 2006

Conditions

Hepatitis C

Keywords

liver fibrosisportal pressureantiviral therapy

Outcome Measures

Primary Outcomes (1)

  • Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop

Secondary Outcomes (2)

  • Sustained virological response (persistent HCV-RNA negativation)

  • Safety of antiviral therapy

Interventions

Pegylated interferon and ribavirinDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Unit, Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 17484872DERIVED

MeSH Terms

Conditions

Hepatitis CLiver Cirrhosis

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Xavier Forns, MD

    Liver Unit, Hospital Clinic, Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2006

First Posted

October 4, 2006

Study Start

July 1, 2001

Study Completion

March 1, 2006

Last Updated

October 6, 2006

Record last verified: 2006-10

Locations

ES(1)