NCT04942886Enrolling by invitation
Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
A Randomized, Prospective, Comparative Study of the Effectiveness of Prophylactic Entecavir Treatment for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with allogeneic hematopoietic stem cell transplantation.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- First submitted
- 15 Jun 2021
- Start date
- 21 Aug 2021
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Seoul St. Mary's Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT04942886
What you commit to
- Study type: Interventional
- Planned participants: 226
- From 21 Aug 2021 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion Criteria:
- Age: 19 - 70
- Patients receiving allogeneic hematopoietic stem cell transplantation
- HBV serologic test: HBsAg (-), anti-HBc IgG (+) before receiving allogeneic hematopoietic stem cell transplantation
- ECOG performence: 0-2
- patients with informed consent
- Exclusion Criteria:
- HBV DNA (+, ≥10 IU/mL) at the time of screening
- Receiving hematopoietic stem cell transplantation from donor with HBsAg+
- Combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis C etc.)
- HIV (+)
- Previous antiviral therapy history for chronic hepatitis B
- Other concomitant malignancy
- Combined autoimmune disease (rheumatic arthritis, SLE etc)
- CTP class B, C
- Decompensated complications (ascites, hepatic encephalopathy etc.)
- Active tuberculosis
- Patients with lymphoma
- Patients receiving autologous hematopoietic stem cell transplantation
Age in the registry: 19 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jeong Won Jang Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.