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 HBsAgHBV-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
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