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Completed

NCT Number: NCT02375906

The Hepatitis Delta International Network

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.

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Key information

Conditions

Hepatitis D Digestive System Diseases Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide

    Time frame: 10 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

HepNet Study House, German Liverfoundation

Network

Collaborators

  • German Center for Infection Research
  • Hannover Medical School

Registry information

Official study title

Hepatitis Delta Registry and Research Network- Observational Study

Acronym: HDIN

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2015
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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