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Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ribavirin
Pegylated interferon alpha2a
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Presence of HCV RNA in serum, Absence of graft rejection, Recurrent hepatitis C after liver transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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).

    Full Information

    First Posted
    April 25, 2007
    Last Updated
    April 25, 2007
    Sponsor
    University Hospital, Geneva
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00466219
    Brief Title
    Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Geneva

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C
    Keywords
    Presence of HCV RNA in serum, Absence of graft rejection, Recurrent hepatitis C after liver transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Intervention Type
    Drug
    Intervention Name(s)
    Pegylated interferon alpha2a
    Primary Outcome Measure Information:
    Title
    Biochemical (normalization of serum transaminases levels),
    Title
    virological (disappearance of HCV RNA from serum)
    Title
    and histological (amelioration of the histological signs of hepatitis) response.
    Secondary Outcome Measure Information:
    Title
    Correlation of the above outcome measures with early on-treatment HCV RNA dynamics (if applicable).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francesco Negro, MD
    Organizational Affiliation
    University Hospital, Geneva
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

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