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An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Terminated
CT.gov ID
NCT01861444
Collaborator
(none)
45
Enrollment
1
Location
48
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients treated with Pegasys according to current medical practice will be followed until 24 weeks after the end of treatment.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    45 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    National, Multicenter, Observational Study Evaluating Prevalence, Virological and Clinical Characteristics of Chronic Hepatitis Delta in Romania and Assess Efficacy of Peg-interferon Alfa-2a Treatment in Patients With Chronic Hepatitis D (CHD)
    Study Start Date :
    Mar 1, 2011
    Actual Primary Completion Date :
    Mar 1, 2015
    Actual Study Completion Date :
    Mar 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection [approximately 3.5 years]

    2. Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment [approximately 3.5 years]

    Secondary Outcome Measures

    1. Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D [approximately 3.5 years]

    2. Proportion of chronic hepatitis D patients with liver cirrhosis [approximately 3.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    For epidemiological part of the study:

    • Adult patients >/= 18 years of age

    • Positive HBsAg for at least 6 months

    For the non-interventional section of the study

    • Adult patients, >/= 18 years of age

    • Positive HBsAg for at least 6 months

    • Positive anti-delta and positive HDV RNA by PCR

    • Elevated serum ALT >/= 2x ULN

    Exclusion Criteria:
    Patients with any of the following will not be eligible for treatment with Pegasys:

    • History of neurological disease

    • History of severe psychiatric disease

    • Decompensated diabetes

    • History of immunologically mediated disease

    • History of severe cardiac disease

    • History or other evidence of severe chronic pulmonary disease

    • Inadequate hematologic function

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bucharest Romania 022328

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT01861444
    Other Study ID Numbers:
    • ML25581
    First Posted:
    May 23, 2013
    Last Update Posted:
    Nov 2, 2016
    Last Verified:
    Nov 1, 2016
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis D
    Hepatitis D, Chronic
    Hepatitis
    Hepatitis, Chronic

    Study Results

    No Results Posted as of Nov 2, 2016