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HDIN: The Hepatitis Delta International Network

Sponsor
HepNet Study House, German Liverfoundation (Other)
Overall Status
Completed
CT.gov ID
NCT02375906
Collaborator
German Center for Infection Research (Other), Hannover Medical School (Other)
2,000
Enrollment
18
Locations
102.9
Actual Duration (Months)
111.1
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hepatitis delta is a major health problem, not only because of the severity of the disease, but also due to the lack of effective antiviral treatment. To improve the current therapeutic options, a better understanding of the pathophysiology is essential. Reliable research in this direction is only possible with large patient study groups. However, given the geographic distribution of hepatitis delta, larger patient cohorts would only be possible through multicenter collaboration.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The hepatitis international network cohort is a multicenter, observational study that will build up a research registry of HDV patients all over the world.

    The aims of this project are:

    1. Collect clinical information from hepatitis delta patients from multiple centers distributed worldwide in order to build up a large database that will enable and facilitate further research on chronic hepatitis delta.

    2. To better inform patients about their viral infection, present status and evolution of liver disease throughout time. To give them the tools needed to inform other peers and medical professionals about the significance and consequences of a chronic hepatitis delta infection.

    3. To allow the participating physicians to track course of the disease, therapies, signs and symptoms of the hepatitis delta patients included by their center.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Hepatitis Delta Registry and Research Network- Observational Study
    Actual Study Start Date :
    Nov 1, 2013
    Actual Primary Completion Date :
    May 31, 2022
    Actual Study Completion Date :
    May 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide [10 years]

    Secondary Outcome Measures

    1. HDV-RNA HBsAg [10 years]

    2. HBV-DNA [10 years]

    3. Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Positive HBs antigen and antiHDV for longer than 6 months.

    Exclusion Criteria:

    Absence of any cause of relevant liver disease other than HDV (i.e. hemochromatosis, autoimmune hepatitis, alcoholic or toxic liver disease, etc.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Vienna; Internal Med.III Vienna Austria
    2 Antwerpen University Hospital Edegem Belgium
    3 Centro de Pesquisa em Medicina Tropical Rondonia Brazil
    4 Medical Center Mrcheveli Tiflis Georgia
    5 Medizinisches Infektiologiezentrum Berlin Germany 10439
    6 Medizinische Klinik I Charite- Campus Benjamin Franklin Berlin Germany
    7 Universitätsklinikum Giessen-Marburg Gießen Germany
    8 Medizinische Hochschule Hannover Hannover Germany
    9 Dep.of Medicine University of Thessalony Larissa Greece
    10 Centro di ricerca per lo studio della Epatiti Bologna Italy
    11 Gastroenterology Casa Sollievo della Sofferenza Hospital San Giovanni Rotondo Italy
    12 A.O.U. Citta della Salute e della Scienza di Torino Torino Italy
    13 The University of Medicine "Nicolae Testimitanu" Chisinau Moldova, Republic of
    14 Dept.of Medicine Aga Khan University Karachi Pakistan
    15 Liverstomach Clinic Karachi Pakistan
    16 Clinical Hospital of Infectious Disease "dr. Victor Babes" Bucharest Romania
    17 Hospital Vall d´Hebron Barcelona Spain
    18 Vietnamese-German Center for Medical Research Hanoi Vietnam

    Sponsors and Collaborators

    • HepNet Study House, German Liverfoundation
    • German Center for Infection Research
    • Hannover Medical School

    Investigators

    • Principal Investigator: Michael P Manns, Prof. Dr., Hannover Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HepNet Study House, German Liverfoundation
    ClinicalTrials.gov Identifier:
    NCT02375906
    Other Study ID Numbers:
    • HepNet-HDIN
    First Posted:
    Mar 3, 2015
    Last Update Posted:
    Jun 2, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by HepNet Study House, German Liverfoundation
    HDV, hepatitis delta
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis D
    Hepatitis

    Study Results

    No Results Posted as of Jun 2, 2022