The Hepatitis Delta International Network (HDIN)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02375906 |
Recruitment Status :
Completed
First Posted : March 3, 2015
Last Update Posted : June 2, 2022
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Condition or disease |
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Hepatitis D |
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] |
Actual Enrollment : | 2000 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Target Follow-Up Duration: | 10 Years |
Official Title: | Hepatitis Delta Registry and Research Network- Observational Study |
Actual Study Start Date : | November 2013 |
Actual Primary Completion Date : | May 31, 2022 |
Actual Study Completion Date : | May 31, 2022 |

- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.)

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

Principal Investigator: | Michael P Manns, Prof. Dr. | Hannover Medical School |
Publications of Results:
Responsible Party: | HepNet Study House, German Liverfoundation |
ClinicalTrials.gov Identifier: | NCT02375906 |
Other Study ID Numbers: |
HepNet-HDIN |
First Posted: | March 3, 2015 Key Record Dates |
Last Update Posted: | June 2, 2022 |
Last Verified: | June 2022 |
HDV, hepatitis delta |
Hepatitis A Hepatitis D Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections |