The Hepatitis Delta International Network (HDIN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02375906|
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : March 1, 2021
|Condition or disease|
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 [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|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 2022|
|Estimated Study Completion Date :||November 2023|
- Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide [ Time Frame: 10 years ]
- HDV-RNA HBsAg [ Time Frame: 10 years ]
- HBV-DNA [ Time Frame: 10 years ]
- Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide [ Time Frame: 10 years ]
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
|Contact: Heiner Wedemeyer, Prof.Dr.||firstname.lastname@example.org|
|Contact: Petra Dörge, Dr.||email@example.com|
|Principal Investigator:||Michael P Manns, Prof. Dr.||Hannover Medical School|