The Hepatitis Delta International Network (HDIN)

June 1, 2022 updated by: HepNet Study House, German Liverfoundation

Hepatitis Delta Registry and Research Network- Observational Study

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna; Internal Med.III
  • Belgium
      • Edegem, Belgium
        • Antwerpen University Hospital
  • Brazil
      • Rondonia, Brazil
        • Centro de Pesquisa em Medicina Tropical
  • Georgia
      • Tiflis, Georgia
        • Medical Center Mrcheveli
  • Germany
      • Berlin, Germany, 10439
        • Medizinisches Infektiologiezentrum
      • Berlin, Germany
        • Medizinische Klinik I Charite- Campus Benjamin Franklin
      • Gießen, Germany
        • Universitätsklinikum Gießen-Marburg
      • Hannover, Germany
        • Medizinische Hochschule Hannover
  • Greece
      • Larissa, Greece
        • Dep.of Medicine University of Thessalony
  • Italy
      • Bologna, Italy
        • Centro di ricerca per lo studio della Epatiti
      • San Giovanni Rotondo, Italy
        • Gastroenterology Casa Sollievo della Sofferenza Hospital
      • Torino, Italy
        • A.O.U. Città della Salute e della Scienza di Torino
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • The University of Medicine "Nicolae Testimitanu"
  • Pakistan
      • Karachi, Pakistan
        • Dept.of Medicine Aga Khan University
      • Karachi, Pakistan
        • Liverstomach Clinic
  • Romania
      • Bucharest, Romania
        • Clinical Hospital of Infectious Disease "dr. Victor Babes"
  • Spain
      • Barcelona, Spain
        • Hospital Vall d´hebron
  • Vietnam
      • Hanoi, Vietnam
        • Vietnamese-German Center for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic hepatitis delta will be screened regardless of HDV or HBV genotype

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
HDV-RNA HBsAg
Time Frame: 10 years
10 years
HBV-DNA
Time Frame: 10 years
10 years
Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HepNet Study House, German Liverfoundation

Collaborators

Hannover Medical School
German Center for Infection Research

Investigators

  • Principal Investigator: Michael P Manns, Prof. Dr., Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HepNet-HDIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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