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NCT03511794 · ClinicalTrials.gov registry record
Effectiveness of the Hepatitis B Vaccine Post-Hematopoietic Stem Cell Transplant
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 52
- Enrollment target
NCT03511794: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT03511794 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03511794 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
Study Summary
Background: Stem cell transplants (SCTs) are important in treating many diseases. There are two main types of transplants. Autologous stem cells come from the person getting the cells. Allogeneic stem cells come from another person. The risk of hepatitis B virus (HBV) is high after allogeneic SCT. Even if a person receives the HBV vaccine after transplant, he or she may not really be immune to HBV. The person may become immune only after repeated series of the vaccine. Researchers need to learn more about the HBV vaccine in people after transplant so it can be most effective. Objective: To assess the rate of achieved HBV immunity for people who had an SCT who did not become immune with the first vaccine series and require 2 or more series. Eligibility: People who have had at least 1 dose of the HBV vaccine and were enrolled in these protocols: 99-H-0050, 10-H-0154, and 08-H-0046 Design: Participants will be screened in the other protocols. Participants data and medical charts will be reviewed. Data from up to 350 participants who had transplants before March 2016 will be reviewed. Participants data will be collected: Demographic data Type of transplant Type of donor Clinical information about the transplant...
Primary Outcome
to assess the rate of achieved immunity for those patients that do not achieve immunity with the first vaccine series and require two or more vaccine series
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2018-04-13 |
| Est. Completion | 2022-02-02 |
What the finished NCT03511794 record still lists
NCT03511794 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03511794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03511794 about?
NCT03511794 is a clinical study titled "Effectiveness of the Hepatitis B Vaccine Post-Hematopoietic Stem Cell Transplant". Background: Stem cell transplants (SCTs) are important in treating many diseases. There are two main types of transplants. Autologous stem cells come from the person getting the cells. Allogeneic stem cells come from another person. The risk of hepatitis B virus (HBV) is high after allogeneic SCT. ...
What is the current status of trial NCT03511794?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2018-04-13. Estimated completion is 2022-02-02.
Who is sponsoring clinical trial NCT03511794?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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