Clinical trial NCT02375906: The Hepatitis Delta International Network
Official title: Hepatitis Delta Registry and Research Network- Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis D
Keywords: HDV, hepatitis delta
Lead sponsor: HepNet Study House, German Liverfoundation
Sponsor class: NETWORK
Collaborators: name: German Center for Infection Research
name: Hannover Medical School
First posted: 2015-03-03
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis delta will be screened regardless of HDV or HBV genotype

Brief 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.

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 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.)

Primary outcomes:
measure: Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide
timeFrame: 10 years
Secondary outcomes:
measure: HDV-RNA HBsAg
timeFrame: 10 years
measure: HBV-DNA
timeFrame: 10 years
measure: Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide
timeFrame: 10 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna; Internal Med.III
city: Edegem
country: Belgium
facility: Antwerpen University Hospital
city: Rondonia
country: Brazil
facility: Centro de Pesquisa em Medicina Tropical
city: Tiflis
country: Georgia
facility: Medical Center Mrcheveli
city: Berlin
country: Germany
facility: Medizinisches Infektiologiezentrum
city: Berlin
country: Germany
facility: Medizinische Klinik I Charite- Campus Benjamin Franklin
city: Gießen
country: Germany
facility: Universitätsklinikum Giessen-Marburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Larissa
country: Greece
facility: Dep.of Medicine University of Thessalony
city: Bologna
country: Italy
facility: Centro di ricerca per lo studio della Epatiti
city: San Giovanni Rotondo
country: Italy
facility: Gastroenterology Casa Sollievo della Sofferenza Hospital
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino
city: Chisinau
country: Moldova, Republic of
facility: The University of Medicine "Nicolae Testimitanu"
city: Karachi
country: Pakistan
facility: Dept.of Medicine Aga Khan University
city: Karachi
country: Pakistan
facility: Liverstomach Clinic
city: Bucharest
country: Romania
facility: Clinical Hospital of Infectious Disease "dr. Victor Babes"
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Hanoi
country: Vietnam
facility: Vietnamese-German Center for Medical Research
Study officials:
affiliation: Hannover Medical School
name: Michael P Manns, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.