The Hepatitis Delta International Network

NCT ID: NCT02375906

Last Updated: 2022-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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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:

i. 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.

ii. 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.

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

Conditions

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Hepatitis D

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Center for Infection Research

OTHER

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role collaborator

HepNet Study House, German Liverfoundation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael P Manns, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Medical University of Vienna; Internal Med.III

Vienna, , Austria

Site Status

Antwerpen University Hospital

Edegem, , Belgium

Site Status

Centro de Pesquisa em Medicina Tropical

Rondônia, , Brazil

Site Status

Medical Center Mrcheveli

Tbilisi, , Georgia

Site Status

Medizinisches Infektiologiezentrum

Berlin, , Germany

Site Status

Medizinische Klinik I Charite- Campus Benjamin Franklin

Berlin, , Germany

Site Status

Universitätsklinikum Giessen-Marburg

Giessen, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Dep.of Medicine University of Thessalony

Larissa, , Greece

Site Status

Centro di ricerca per lo studio della Epatiti

Bologna, , Italy

Site Status

Gastroenterology Casa Sollievo della Sofferenza Hospital

San Giovanni Rotondo, , Italy

Site Status

A.O.U. Citta della Salute e della Scienza di Torino

Torino, , Italy

Site Status

The University of Medicine "Nicolae Testimitanu"

Chisinau, , Moldova

Site Status

Dept.of Medicine Aga Khan University

Karachi, , Pakistan

Site Status

Liverstomach Clinic

Karachi, , Pakistan

Site Status

Clinical Hospital of Infectious Disease "dr. Victor Babes"

Bucharest, , Romania

Site Status

Hospital Vall d´Hebron

Barcelona, , Spain

Site Status

Vietnamese-German Center for Medical Research

Hanoi, , Vietnam

Site Status

Countries

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Austria Belgium Brazil Georgia Germany Greece Italy Moldova Pakistan Romania Spain Vietnam

References

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Wranke A, Pinheiro Borzacov LM, Parana R, Lobato C, Hamid S, Ceausu E, Dalekos GN, Rizzetto M, Turcanu A, Niro GA, Lubna F, Abbas M, Ingiliz P, Buti M, Ferenci P, Vanwolleghem T, Hayden T, Dashdorj N, Motoc A, Cornberg M, Abbas Z, Yurdaydin C, Manns MP, Wedemeyer H, Hardtke S; Hepatitis Delta International Network. Clinical and virological heterogeneity of hepatitis delta in different regions world-wide: The Hepatitis Delta International Network (HDIN). Liver Int. 2018 May;38(5):842-850. doi: 10.1111/liv.13604. Epub 2017 Oct 26.

Reference Type RESULT
PMID: 28963781 (View on PubMed)

Other Identifiers

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HepNet-HDIN

Identifier Type: -

Identifier Source: org_study_id

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