Hepatitis DHDINNCT02375906
The Hepatitis Delta International Network
An observational study of Hepatitis D, run by HepNet Study House, German Liverfoundation at 18 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis D
- How many people
- 2,000 participants
- Where
- 18 sitesin 12 countries
- Study dates
- Nov 2013to 31 May 2022
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic hepatitis delta will be screened regardless of HDV or HBV genotype
Who may be able to join
- Positive HBs antigen and antiHDV for longer than 6 months.
Who cannot join
- Absence of any cause of relevant liver disease other than HDV (i.e. hemochromatosis, autoimmune hepatitis, alcoholic or toxic liver disease, etc.)
Trial locations and contacts
18 sites in 12 countries.
18 sites in 12 countries
Germany4 sites
Medizinisches Infektiologiezentrum
Berlin, 10439
Medizinische Klinik I Charite- Campus Benjamin Franklin
Berlin
Universitätsklinikum Giessen-Marburg
Giessen
Medizinische Hochschule Hannover
Hanover
Italy3 sites
Centro di ricerca per lo studio della Epatiti
Bologna
Gastroenterology Casa Sollievo della Sofferenza Hospital
San Giovanni Rotondo
A.O.U. Citta della Salute e della Scienza di Torino
Torino
Pakistan2 sites
Dept.of Medicine Aga Khan University
Karachi
Liverstomach Clinic
Karachi
Romania1 site
Clinical Hospital of Infectious Disease "dr. Victor Babes"
Bucharest
About this study
Official title: Hepatitis Delta Registry and Research Network- Observational Study
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.
Read the 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:
- 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.
- Conditions
- Hepatitis D
- Keywords
- HDV, hepatitis delta
- Medical subject headings
- Hepatitis D
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide
Measured: 10 years
Secondary outcomes (3)
HDV-RNA HBsAg
Measured: 10 years
HBV-DNA
Measured: 10 years
Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startNov 2013
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- HepNet Study House, German Liverfoundation
- Sponsor type
- Research network
- Collaborators
- German Center for Infection Research, Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Michael P Manns, Prof. Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375906
- Sponsor's protocol ID
- HepNet-HDIN
- Acronym
- HDIN
- Status last verified
- Jun 2022
- First submitted
- 19 Feb 2015
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28963781
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis Delta Registry and Research Network- Observational Study
- ClinicalTrials.gov ID
- NCT02375906
- Acronym / sponsor ID
- HDIN / HepNet-HDIN
- Conditions
- Hepatitis D
- Keywords
- HDV, hepatitis delta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- HepNet Study House, German LiverfoundationResearch network
- Collaborators
- German Center for Infection Research, Hannover Medical School
- Study start
- Nov 2013 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic hepatitis delta will be screened regardless of HDV or HBV genotype
Key inclusion criteria (1 listed)
- Positive HBs antigen and antiHDV for longer than 6 months.
Key exclusion criteria (1 listed)
- Absence of any cause of relevant liver disease other than HDV (i.e. hemochromatosis, autoimmune hepatitis, alcoholic or toxic liver disease, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide
Time frame: 10 years
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Results publication: PubMed 28963781Wranke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Manns, Prof. Dr. principal investigator
Hannover Medical School
18 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis D, run by HepNet Study House, German Liverfoundation at 18 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Italy, Pakistan, Austria, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.