Last reviewed · How we verify
NCT04199819: OBI
Detecting Occult HBV Infection in Liver Donors Positive for Antibody to Hepatitis B Core Antigen (Anti-HBc)
NA trial testing entecavir in Occult Hepatitis B in 100 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | The University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 January 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- entecavir (ENTECAVIR) — full drug profile →
Conditions studied
- Occult Hepatitis B — all drugs for Occult Hepatitis B →
- Liver Transplant; Complications — all drugs for Liver Transplant; Complications →
Sponsor
The University of Hong Kong
Who can join
18 and older, any sex, with Occult Hepatitis B or Liver Transplant; Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
After LT, long-term immunosuppressive therapy is required to prevent organ rejection. Therefore, for organs which may harbour OBI, there is a risk of reactivation which may result in liver graft failure. As a consequence, all patients who receive an anti-HBc positive graft will receive antiviral prophylaxis. Currently, all such patients will be commenced on life-long entecavir, which is highly effective in preventing reactivation.2 One major disadvantage of using such a blanket approach is that a significant proportion of anti-HBc donors may not actually have underlying occult HBV infection, and recipients of such grafts may not require lifelong antiviral therapy. Current markers such as HBsAg and HBV DNA are not sensitive enough to detect the presence of OBI. This is the first trial proposed to look at the efficacy of these novel HBV biomarkers in identifying occult HBV infection when used in combination, and to identify patients who will not need long term antiviral prophylaxis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04199819
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of entecavir
Trials testing the same drug.
- NCT00388674 — Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection · completed
Other The University of Hong Kong trials
Trials by the same sponsor.
- NCT05981430 — Fecal Microbiota Transplantation for Decolonization of Carbapenem-resistant Enterobacteriaceae · NA · not yet recruiting
- NCT07478757 — Assessing the Effectiveness of Low-Dose Computed Tomography in Lung Cancer Screening for High-Risk Smokers: A Randomized · NA · not yet recruiting
- NCT07448649 — Chatbot-Assisted Advance Care Planning Education for Family Members · NA · not yet recruiting
- NCT07484932 — TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer · NA · not yet recruiting
- NCT07531589 — BrainLive Connect: Non-professional Delivered CST for People Living With Dementia · NA · recruiting
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 NCT04199819 (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 The University of Hong Kong
- Last refreshed: 23 May 2022
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/NCT04199819.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing