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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02375906
Other study ID # HepNet-HDIN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2013
Est. completion date May 31, 2022

Study information

Verified date June 2022
Source HepNet Study House, German Liverfoundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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: 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.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.)

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (3)

Lead Sponsor Collaborator
HepNet Study House, German Liverfoundation German Center for Infection Research, Hannover Medical School

Countries where clinical trial is conducted

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

References & Publications (1)

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, W — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide 10 years
Secondary HDV-RNA HBsAg 10 years
Secondary HBV-DNA 10 years
Secondary Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide 10 years
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