Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00466219
First received: April 25, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Ribavirin
Drug: Pegylated interferon alpha2a
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Biochemical (normalization of serum transaminases levels),
  • virological (disappearance of HCV RNA from serum)
  • and histological (amelioration of the histological signs of hepatitis) response.

Secondary Outcome Measures:
  • Correlation of the above outcome measures with early on-treatment HCV RNA dynamics (if applicable).

Estimated Enrollment: 25
Study Start Date: May 2002
Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466219

Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Francesco Negro, MD University Hospital, Geneva
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00466219     History of Changes
Other Study ID Numbers: SASL17
Study First Received: April 25, 2007
Last Updated: April 25, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Presence of HCV RNA in serum
Absence of graft rejection
Recurrent hepatitis C after liver transplantation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014