CClinicalTrials.gg
CompletedNCT00383864Updated Oct 6, 2006

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

A Phase 4 interventional study of Pegylated interferon and ribavirin in Hepatitis C, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2006-10-06.

Sponsored by Hospital Clinic of Barcelona · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Hepatitis C

Keywords

  • liver fibrosis
  • portal pressure
  • antiviral therapy
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 55 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants

Interventions

  • DrugPegylated interferon and ribavirin
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Sustained virological response (persistent HCV-RNA negativation)

  2. Safety of antiviral therapy

07

Study locations

1 site
  • Liver Unit, Hospital Clinic
    Barcelona, 08036, Spain
08

References and documents

Publications

  • 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. PubMed 17484872 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00383864
Lead sponsor
Hospital Clinic of Barcelona
Collaborators
Schering-Plough
First posted
Oct 4, 2006
Start date
Jul 2001
Completion
Mar 2006
Last update
Oct 6, 2006

Study contacts

Xavier Forns, MD
principal investigator · Liver Unit, Hospital Clinic, Barcelona
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2006. You cannot join it, but the record below documents what was studied.

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