The Hepatitis Delta International Network

Hepatitis D Clinical Trial

— HDIN  

Official title:

Hepatitis Delta Registry and Research Network- Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375906
• Other study ID #: HepNet-HDIN
• Status: Completed
• 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
• 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.)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D

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