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The Hepatitis Delta International Network (HDIN)

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ClinicalTrials.gov Identifier: NCT02375906
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
German Center for Infection Research
MHH-Hannover Medical School
Information provided by (Responsible Party):
HepNet Study House, German Liverfoundation

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.

Condition or disease
Hepatitis D

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 10 Years
Official Title: Hepatitis Delta Registry and Research Network- Observational Study
Study Start Date : November 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. HDV-RNA HBsAg [ Time Frame: 10 years ]
  2. HBV-DNA [ Time Frame: 10 years ]
  3. Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis delta will be screened regardless of HDV or HBV genotype
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.)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375906


Contacts
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Contact: Heiner Wedemeyer, Prof.Dr. heiner.wedemeyer@uk-essen.de
Contact: Petra Dörge, Dr. doerge.petra@mh-hannover.de

Locations
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Austria
Medical University of Vienna; Internal Med.III Not yet recruiting
Vienna, Austria
Contact: Peter Ferenci, Prof. dr.         
Contact: Swoboda         
Belgium
Antwerpen University Hospital Recruiting
Edegem, Belgium
Contact: Thomas Vanwolleghem, Prof.         
Contact: Erwin Ho         
Brazil
Centro de Pesquisa em Medicina Tropical Recruiting
Rondonia, Brazil
Contact: Juan Miguel Villalobos Salcedo         
Contact: Lourdes M Bozacov         
Georgia
Medical Center Mrcheveli Recruiting
Tiflis, Georgia
Contact: David Metreveli, Dr         
Contact: Irakli Rtskhiladze, Dr         
Germany
Medizinisches Infektiologiezentrum Recruiting
Berlin, Germany, 10439
Contact: Patrick Ingiliz, Dr.med.         
Principal Investigator: A Baumgarten, Dr.med.         
Medizinische Klinik I Charite- Campus Benjamin Franklin Recruiting
Berlin, Germany
Contact: Marion Muche, Dr.         
Contact: Christina Grunow         
Universitätsklinikum Giessen-Marburg Recruiting
Gießen, Germany
Contact: Janina Trauth, Dr.         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Contact: Markus Cornberg, Prof. Dr.         
Greece
Dep.of Medicine University of Thessalony Recruiting
Larissa, Greece
Contact: Georg N Dalekos, Prof.         
Contact: Zachoo Kalliopi, Dr.         
Italy
Centro di ricerca per lo studio della Epatiti Not yet recruiting
Bologna, Italy
Contact: Stefano Brillianti, Prof.         
Gastroenterology Casa Sollievo della Sofferenza Hospital Recruiting
San Giovanni Rotondo, Italy
Contact: Grazia A Niro, Prof.         
A.O.U. Citta della Salute e della Scienza di Torino Recruiting
Torino, Italy
Contact: Maria Rizzetto, Prof.         
Contact: Antonella Olivero       antonella.olivero@unito.it   
Moldova, Republic of
The University of Medicine "Nicolae Testimitanu" Recruiting
Chisinau, Moldova, Republic of
Contact: Adela Tureceanu, Prof.         
Pakistan
Dept.of Medicine Aga Khan University Recruiting
Karachi, Pakistan
Contact: Saeed Hamid, Prof.         
Liverstomach Clinic Recruiting
Karachi, Pakistan
Contact: Zaigham Abbas, Prof.         
Romania
Clinical Hospital of Infectious Disease "dr. Victor Babes" Recruiting
Bucharest, Romania
Contact: Ceausu Emanoil, Prof.         
Contact: George Gherlan, Dr.         
Spain
Hospital Vall d´Hebron Recruiting
Barcelona, Spain
Contact: Maria Buti, Prof.         
Contact: Adriana Palom         
Vietnam
Vietnamese-German Center for Medical Research Recruiting
Hanoi, Vietnam
Contact: Thirumalaisamy P Velavan         
Sponsors and Collaborators
HepNet Study House, German Liverfoundation
German Center for Infection Research
MHH-Hannover Medical School
Investigators
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Principal Investigator: Michael P Manns, Prof. Dr. Hannover Medical School

Additional Information:

Publications of Results:
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Responsible Party: HepNet Study House, German Liverfoundation
ClinicalTrials.gov Identifier: NCT02375906     History of Changes
Other Study ID Numbers: HepNet-HDIN
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Keywords provided by HepNet Study House, German Liverfoundation:
HDV, hepatitis delta
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis D
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections