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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	13 June 2022
Main ID:	NCT02375906
Date of registration:	19/02/2015
Prospective Registration:	No
Primary sponsor:	HepNet Study House, German Liverfoundation
Public title:	The Hepatitis Delta International Network HDIN
Scientific title:	Hepatitis Delta Registry and Research Network- Observational Study
Date of first enrolment:	November 2013
Target sample size:	2000
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02375906
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Austria	Belgium	Brazil	Georgia	Germany	Greece	Italy	Moldova, Republic of
Pakistan	Romania	Russian Federation	Spain	Turkey	Vietnam

Contacts

Name:	Michael P Manns, Prof. Dr.
Address:
Telephone:
Email:
Affiliation:	Hannover Medical School

Key inclusion & exclusion criteria

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.)

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis D

Intervention(s)

Primary Outcome(s)

Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide [Time Frame: 10 years]

Secondary Outcome(s)

Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide [Time Frame: 10 years]

HBV-DNA [Time Frame: 10 years]

HDV-RNA HBsAg [Time Frame: 10 years]

Secondary ID(s)

HepNet-HDIN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

German Center for Infection Research

Hannover Medical School

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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