Last reviewed · How we verify
NCT05903742: DREAM-2
Standardising Care for Hepatitis Delta in the Netherlands
trial in Hepatitis D in 80 participants. Currently enrolling.
1 September 2030
Quick facts
| Lead sponsor | Erasmus Medical Center |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 22 January 2024 |
| Primary completion | 1 September 2030 |
| Estimated completion | 1 September 2031 |
| Sites | 1 location across Netherlands |
Conditions studied
- Hepatitis D — all drugs for Hepatitis D →
Sponsor
Erasmus Medical Center
Who can join
18 and older, any sex, with Hepatitis D. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rationale: Hepatitis delta virus (HDV) is a defective RNA virus that requires presence of hepatitis B virus (HBV) to complete virion assembly and secretion. HBV-HDV coinfection ("hepatitis delta") has been associated with severe liver injury that may result in rapid progression to cirrhosis and hepatic decompensation, as well as a higher risk of liver cancer when compared to patients with HBV mono-infection. Given the low incidence of hepatitis D, experience in caring for individuals with hepatitis delta is limited and management practices vary. Objective: Generate prospective follow-up data to increase our understanding of this rare disease. Study design: Prospective observational cohort study spanning 5 years, during which we will collect standard clinical data as well as blood samples and quality of life questionnaires. Study population: hepatitis delta patients aged ≥18 years Intervention (if applicable): not applicable Main study parameters/endpoints: Incidence of liver related events (liver cancer, (decompensation of) cirrhosis, liver transplantation) during follow-up and changes in markers of viral replication, inflammatory activity and liver stiffness over time. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation can be considered negligible and the burden can be considered minimal. The only additional action that the participants must perform are the filling out of two annual quality of life questionnaires, which are considered non-invasive, and collection of 10 ml blood during regular blood sample collections
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05903742
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatitis D
Currently open trials in the same condition.
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- NCT06504485 — Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bule · recruiting
- NCT06397859 — Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrho · recruiting
- NCT06264583 — HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection · recruiting
- NCT05936073 — DELTA DESCRIBE: the French Collaborative Project · recruiting
Other Erasmus Medical Center trials
Trials by the same sponsor.
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- NCT07383194 — Prediction Models for LDLT Outcomes · not yet recruiting
- NCT07426575 — Evaluating the Usability of New Dialysis Bags · not yet recruiting
- NCT07329296 — The Regenerative Capacity of the Donor Liver After Living Donor Liver Transplantation: an Ambidirectional Cohort Study · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05903742 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Erasmus Medical Center
- Last refreshed: 3 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05903742.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing