The Hepatitis Delta International Network

Completed

• Conditions: Hepatitis D

• Registration Number: NCT02375906
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-03-03
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide	10 years

Secondary Outcome Measures

Name	Time	Method
HDV-RNA HBsAg	10 years
HBV-DNA	10 years
Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide	10 years

Trial Locations

Locations (18)

Centro de Pesquisa em Medicina Tropical; 🇧🇷 Rondonia, Brazil

Universitätsklinikum Giessen-Marburg; 🇩🇪 Gießen, Germany

A.O.U. Citta della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy

Medical University of Vienna; Internal Med.III; 🇦🇹 Vienna, Austria

Medical Center Mrcheveli; 🇬🇪 Tiflis, Georgia

Centro di ricerca per lo studio della Epatiti; 🇮🇹 Bologna, Italy

Hospital Vall d´Hebron; 🇪🇸 Barcelona, Spain

Vietnamese-German Center for Medical Research; 🇻🇳 Hanoi, Vietnam

Antwerpen University Hospital; 🇧🇪 Edegem, Belgium

Medizinische Klinik I Charite- Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Dep.of Medicine University of Thessalony; 🇬🇷 Larissa, Greece

Gastroenterology Casa Sollievo della Sofferenza Hospital; 🇮🇹 San Giovanni Rotondo, Italy

Dept.of Medicine Aga Khan University; 🇵🇰 Karachi, Pakistan

Liverstomach Clinic; 🇵🇰 Karachi, Pakistan

Clinical Hospital of Infectious Disease "dr. Victor Babes"; 🇷🇴 Bucharest, Romania

The University of Medicine "Nicolae Testimitanu"; 🇲🇩 Chisinau, Moldova, Republic of

Medizinisches Infektiologiezentrum; 🇩🇪 Berlin, Germany