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The Hepatitis Delta International Network (HDIN)

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ClinicalTrials.gov Identifier: NCT02375906
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : March 1, 2021
Sponsor:
Collaborators:
German Center for Infection Research
Hannover Medical School
Information provided by (Responsible Party):
HepNet Study House, German Liverfoundation

Study Description
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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.

Condition or disease
Hepatitis D

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide [ Time Frame: 10 years ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis delta will be screened regardless of HDV or HBV genotype
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.)

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Heiner Wedemeyer, Prof.Dr. heiner.wedemeyer@uk-essen.de
Contact: Petra Dörge, Dr. doerge.petra@mh-hannover.de

Locations
Show Show 18 study locations
Sponsors and Collaborators
HepNet Study House, German Liverfoundation
German Center for Infection Research
Hannover Medical School
Investigators
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Principal Investigator: Michael P Manns, Prof. Dr. Hannover Medical School
More Information
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Additional Information:

Publications of Results:

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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: March 1, 2021
Last Verified: February 2021
Keywords provided by HepNet Study House, German Liverfoundation:
HDV, hepatitis delta
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis D
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections