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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 : January 18, 2020
Sponsor:
Collaborators:
German Center for Infection Research
MHH-Hannover Medical School
Information provided by (Responsible Party):
HepNet Study House, German Liverfoundation

Tracking Information
First Submitted Date February 19, 2015
First Posted Date March 3, 2015
Last Update Posted Date January 18, 2020
Study Start Date November 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2015)
Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide [ Time Frame: 10 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 25, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Hepatitis Delta International Network
Official Title Hepatitis Delta Registry and Research Network- Observational Study
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with chronic hepatitis delta will be screened regardless of HDV or HBV genotype
Condition Hepatitis D
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Wranke A, Pinheiro Borzacov LM, Parana R, Lobato C, Hamid S, Ceausu E, Dalekos GN, Rizzetto M, Turcanu A, Niro GA, Lubna F, Abbas M, Ingiliz P, Buti M, Ferenci P, Vanwolleghem T, Hayden T, Dashdorj N, Motoc A, Cornberg M, Abbas Z, Yurdaydin C, Manns MP, Wedemeyer H, Hardtke S; Hepatitis Delta International Network. Clinical and virological heterogeneity of hepatitis delta in different regions world-wide: The Hepatitis Delta International Network (HDIN). Liver Int. 2018 May;38(5):842-850. doi: 10.1111/liv.13604. Epub 2017 Oct 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 25, 2015)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2023
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.)

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Heiner Wedemeyer, Prof.Dr. heiner.wedemeyer@uk-essen.de
Contact: Petra Dörge, Dr. doerge.petra@mh-hannover.de
Listed Location Countries Austria,   Belgium,   Brazil,   Georgia,   Germany,   Greece,   Italy,   Moldova, Republic of,   Pakistan,   Romania,   Spain,   Vietnam
Removed Location Countries Russian Federation,   Turkey
 
Administrative Information
NCT Number NCT02375906
Other Study ID Numbers HepNet-HDIN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party HepNet Study House, German Liverfoundation
Study Sponsor HepNet Study House, German Liverfoundation
Collaborators
  • German Center for Infection Research
  • MHH-Hannover Medical School
Investigators
Principal Investigator: Michael P Manns, Prof. Dr. Hannover Medical School
PRS Account HepNet Study House, German Liverfoundation
Verification Date January 2020