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The Hepatitis Delta International Network

Hepatitis Delta Registry and Research Network- Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02375906
Acronym
HDIN
Enrollment
2000
Registered
2015-03-03
Start date
2013-11-30
Completion date
2022-05-31
Last updated
2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis D

Keywords

HDV, hepatitis delta

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.

Interventions

None listed

Sponsors

German Center for Infection Research
CollaboratorOTHER
Hannover Medical School
CollaboratorOTHER
HepNet Study House, German Liverfoundation
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frame
Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide10 years

Secondary

MeasureTime frame
HDV-RNA HBsAg10 years
HBV-DNA10 years
Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide10 years

Countries

Austria, Belgium, Brazil, Georgia, Germany, Greece, Italy, Moldova, Pakistan, Romania, Spain, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026