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Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels

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ClinicalTrials.gov Identifier: NCT00575627
Recruitment Status : Unknown
Verified June 2008 by University of Turin, Italy.
Recruitment status was:  Recruiting
First Posted : December 18, 2007
Last Update Posted : June 4, 2008
Sponsor:
Information provided by:
University of Turin, Italy

Tracking Information
First Submitted Date  ICMJE December 14, 2007
First Posted Date  ICMJE December 18, 2007
Last Update Posted Date June 4, 2008
Study Start Date  ICMJE September 2007
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
To evaluate the efficacy of treatment and the outcome of treated patients compared with a control group of untreated patients. [ Time Frame: 48-72 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
evaluation of liver fibrosis by Fibroscan after 48-72 weeks of inclusion [ Time Frame: 48-72 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels
Official Title  ICMJE Treatment of Chronic Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels With Peginterferon α-2a (40 kDa) Plus Ribavirin
Brief Summary Patients with chronic hepatitis C with persistently normal alanine aminotransferase (ALT) levels have been generally excluded from treatment, because the strong conviction that normal ALT would be synonymous of absence of liver damage. However, recent studies have demonstrated marked liver fibrosis, including cirrhosis, in patients with HCV and persistently normal ALT levels. Up to now, just a sigle randomized, controlled, multicenter study was lead to evaluate the efficacy and safety of combined therapy in patients with chronic hepatitis C and persistently normal serum ALT levels. Aim of our study is evaluate the efficacy of treatment and the outcome of treated patients compared with a control group of untreated patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE Drug: Peg-Interferon alpha2a plus Ribavirin
Peg-Interferon alpha2a: 180 micrograms per week Ribavirin:100-1200 mg/daily
Study Arms  ICMJE
  • No Intervention: 2
  • Experimental: 1
    Drug: peginterferon α-2a (40 kDa) plus ribavirin for 24-48 weeks
    Intervention: Drug: Peg-Interferon alpha2a plus Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 14, 2007)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2010
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Serologic evidence of chronic hepatitis C infection (repeatedly HCV-RNA positive) with persistent normal ALT levels documented on at least 3 occasions, in the last 18 months before screening.
  • Fibroscan performed in the last 3 months
  • Compensated liver disease, Child Pugh score <7
  • Serum HCV-RNA >615 IU/mL
  • Patients who are naïve to any hepatitis C therapy (i.e. have not been previously treated with an interferon or with IFN plus ribavirin)
  • No clinical or radiological evidence of hepatocellular carcinoma and a serum AFP <100 ng/mL within 2 months of randomisation
  • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
  • All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • History or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease (Child Pugh B or C)
  • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) £6 months prior to the first dose of study drug
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
  • Serum creatinine level >1.5 times the upper limit of normal at screening
  • Evidence of current severe psychiatric disease, especially depression within one year of study entry. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, within 12 months prior to study entry. Patients with a previous history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease should be evaluated by a qualified Psychiatrist for study suitability prior to enrolment.
  • History of a severe seizure disorder or current anticonvulsant use History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
  • Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
  • Evidence of drug abuse (including excessive alcohol consumption) within 6 months of study entry
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study
  • Male partners of women who are pregnant
  • Hgb <12 g/dL in women or <13 g/dL in men at screening
  • Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
  • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00575627
Other Study ID Numbers  ICMJE pNNALTHCV
NNALT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Mario Rizzetto - Dipartimento di GastroEpatologia - Università degli Studi di Torino, Università degli Studi di Torino
Study Sponsor  ICMJE University of Turin, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rizzetto Mario Università degli Studi di Torino - Azienda Ospedaliera San Giovanni Battista di Torino, Molinette,
PRS Account University of Turin, Italy
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP