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The Hepatitis Delta International Network

Information source: HepNet Study House, German Liverfoundation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis D

Phase: N/A

Status: Recruiting

Sponsored by: HepNet Study House, German Liverfoundation

Official(s) and/or principal investigator(s):
Michael P Manns, Prof. Dr., Principal Investigator, Affiliation: Hannover Medical School

Overall contact:
Heiner Wedemeyer, Prof.Dr., Email: Wedemeyer.Heiner@mh-hannover.de

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.

Clinical Details

Official title: Hepatitis Delta Registry and Research Network- Observational Study

Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional

Primary outcome: Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide

Secondary outcome:

HDV-RNA HBsAg

HBV-DNA

Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide

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: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.)

Locations and Contacts

Heiner Wedemeyer, Prof.Dr., Email: Wedemeyer.Heiner@mh-hannover.de

Medical University of Vienna; Internal Med.III, Vienna, Austria; Not yet recruiting
Peter Ferenci, Prof. dr.
Swoboda

Fundacao de Medicina Tropical, Manaus, Brazil; Recruiting
Wornei S Braga

Centro de Pesquisa em Medicina Tropical, Rondonia, Brazil; Recruiting
Juan Miguel Villalobos Salcedo
Lourdes M Bozacov

Medical Center Mrcheveli, Tiflis, Georgia; Not yet recruiting
David Metreveli, Dr
Irakli Rtskhiladze, Dr

Medizinische Klinik I Charite- Campus Benjamin Franklin, Berlin, Germany; Not yet recruiting
Marion Muche, Dr.
Christina Grunow

Medizinisches Infektiologiezentrum, Berlin 10439, Germany; Recruiting
Patrick Ingiliz, Dr.med.
A Baumgarten, Dr.med., Principal Investigator

Medizinische Hochschule Hannover, Hannover, Germany; Recruiting
Heiner Wedemeyer, Prof. Dr.

Dep.of Medicine University of Thessalony, Larissa, Greece; Recruiting
Georg N Dalekos, Prof.
Zachoo Kalliopi, Dr.

Gastroenterology Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy; Not yet recruiting
Grazia A Niro, Prof.

Dept.of Medicine Aga Khan University, Karachi, Pakistan; Recruiting
Saeed Hamid, Prof.

Liverstomach Clinic, Karachi, Pakistan; Recruiting
Zaigham Abbas, Prof.

Sverdlovsk Reginal Hepatologial Center, Ekaterinburg, Russian Federation; Not yet recruiting
Elena Bessanova
Tatiana Tobolina

Hospital Vall d´Hebron, Barcelona, Spain; Not yet recruiting
Maria Buti, Prof.
Maria Homs

Ankara University; Faculty of Medicine, Ankara, Turkey; Recruiting
Cihan Yurdaydin

Additional Information

Starting date: November 2013
Last updated: February 25, 2015

Page last updated: August 20, 2015

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