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CompletedNCT00466219Updated Apr 27, 2007

Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

A Phase 3 interventional study of Ribavirin and Pegylated interferon alpha2a in Hepatitis C, sponsored by University Hospital, Geneva. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-04-27.

Sponsored by University Hospital, Geneva · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of the study is to assess whether patients with recurrent hepatitis C after liver transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment for 48 weeks.

Read the detailed description

The aim of the study is to assess whether patients fulfilling the criteria as defined in section 3 will benefit from a treatment with ribavirin/PEG-a-IFN combined treatment. This study will be open to all patients with histologically documented hepatitis C recurring after LT, provided that all inclusion and exclusion criteria, as defined below, are met, and irrespectively of the pattern of response to a previous antiviral treatment (if any).

The benefit will be assessed in terms of biochemical (normalization of serum transaminases levels), virological (disappearance of HCV RNA from serum) and histological (amelioration of the histological signs of hepatitis) response. The presence of a sustained virological response, as defined below in section 6, will also be studied in relation to the early kinetics of serum HCV RNA, in keeping with recent data obtained in chronic hepatitis C patients, which suggest that an early rapid decrease of HCV viremia is associated with a durable response.

02

Conditions studied

  • Hepatitis C

Keywords

  • Presence of HCV RNA in serum
  • Absence of graft rejection
  • Recurrent hepatitis C after liver transplantation
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 25 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 to 65 year old patients, male or female, having undergone a LT for end-stage liver disease due to HCV
  • patients presenting after LT with recurrent HCV infection, documented by presence of HCV RNA in serum, and recurrent hepatitis, diagnosed at histology; the liver biopsy upon which the diagnosis is established must have been performed within the 12 months prior to inclusion; the treatment cannot start within the 6 months following LT
  • alpha fetoprotein value within normal limits obtained within 3 months before entry visit
  • stable immunosuppressive regimen, defined as lack of any therapeutic measures aimed at preventing or treating graft rejection during the three months prior to antiviral therapy

Exclusion criteria

Exclusion Criteria:

  • participation in other clinical trial within 30 days of entry into this protocol
  • patients retransplanted for rejection or for recurrent hepatitis C on the graft
  • patients with a history of cardiovascular disease including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure are excluded
  • presence of HBsAg and/or HIV
  • history of auto-immune disease, including auto-immune hepatitis
  • alcohol consumption exceeding 40 grams per day
  • acute rejection episode within the 3 months prior to inclusion, or current histological features possibly related to underlying rejection
  • hepatocellular carcinoma
  • unresolved biliary complication
  • renal insufficiency (serum creatinine levels above 200 micromol/l)
  • unconjugated bilirubin blood level > 100 micromol/l
  • gammaglutamyl transferase > 20 times the upper limit of normal range
  • prothrombin time below 60% of control (except in case of oral anti-coagulant therapy)
  • neutrophil count less than 1,500/mm3
  • platelet count less than 90,000/mm3
  • hemoglobin below the lower limit of normal of the testing laboratory
  • other organ or bone marrow transplantation
  • current neoplasm and/or anti-tumor chemotherapy
  • current hepatic arterial thrombosis
  • pregnant or breast feeding women; child bearing potential women without adequate contraception throughout the course of therapy
  • psychosis or anti-depressant therapy for uncontrolled clinical depression
  • clinically significant retinal abnormalities
  • thyroid dysfunction (abnormal TSH value with or without clinical symptoms)
  • immunosuppressive therapy with OKT3 or any other anti-lymphocyte serum
  • drug abuse (heroin, cocaine) or substitution therapy during the 12 months prior to inclusion
  • history of ischemic cardiopathy
  • interstitial pneumonitis
  • previous auto-immune hemolysis and all causes of chronic hemolysis
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants

Interventions

  • DrugRibavirin
  • DrugPegylated interferon alpha2a
06

What researchers measure

Primary outcomes

  1. Biochemical (normalization of serum transaminases levels),

  2. virological (disappearance of HCV RNA from serum)

  3. and histological (amelioration of the histological signs of hepatitis) response.

Secondary outcomes

  1. Correlation of the above outcome measures with early on-treatment HCV RNA dynamics (if applicable).

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00466219
Lead sponsor
University Hospital, Geneva
First posted
Apr 27, 2007
Start date
May 2002
Completion
Dec 2006
Last update
Apr 27, 2007

Study contacts

Francesco Negro, MD
principal investigator · University Hospital, Geneva

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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