Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

NCT00466219 | Completed Phase 3

• 1 other identifier: SASL17
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis C

Keywords

Presence of HCV RNA in serum; Absence of graft rejection; Recurrent hepatitis C after liver transplantation

Outcome Measures

Primary Outcomes (3)

• Biochemical (normalization of serum transaminases levels),

• virological (disappearance of HCV RNA from serum)

• 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).

Interventions

Ribavirin DRUG

Pegylated interferon alpha2a DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 year old patients, male or female, having undergone a LT for end-stage liver disease due to HCV
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Francesco Negro, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: May 1, 2002
• Study Completion: December 1, 2006
• Last Updated: April 27, 2007

Record last verified: 2007-04