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NCT04144036 · ClinicalTrials.gov registry record · Phase 1
Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD)
A Phase 1 study, sponsored by Sameem M. Abedin, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04144036: Completed Phase 1 study, sponsored by Sameem M. Abedin, MD.
NCT04144036 is a Phase 1 study that has completed, run by Sameem M. Abedin, MD. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04144036, a Phase 1 study, has completed, sponsored by Sameem M. Abedin, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a single-center Phase I study to determine the maximum tolerated dose and safety of Neihulizumab for the treatment of Minnesota standard-risk aGVHD. Patients undergoing allogeneic transplant with either a myeloablative or non-myeloablative conditioning regimen, and recipients of all donor sources will be enrolled to this trial.
Primary Outcome
The maximum-tolerated dose will be defined as the highest dose level at which no more than one of six treated patients, experiences a dose-limiting toxicity.
Interventions
- BIOLOGICAL Neihulizumab, 3 mg/kg
- DRUG Neihulizumab, 6 mg/kg
- DRUG Neihulizumab, 9 mg/kg
- DRUG Neihulizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2024-07-07 |
| Phase | Phase 1 |
What the finished NCT04144036 record still lists
NCT04144036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Neihulizumab, 3 mg/kg is the first listed.
NCT04144036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04144036 about?
NCT04144036 is a clinical study titled "Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD)". This is a single-center Phase I study to determine the maximum tolerated dose and safety of Neihulizumab for the treatment of Minnesota standard-risk aGVHD. Patients undergoing allogeneic transplant with either a myeloablative or non-myeloablative conditioning regimen, and recipients of all donor so...
What is the current status of trial NCT04144036?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-12-14. Estimated completion is 2024-07-07.
What interventions are being tested in trial NCT04144036?
The interventions under investigation include: Neihulizumab, 3 mg/kg (BIOLOGICAL), Neihulizumab, 6 mg/kg (DRUG), Neihulizumab, 9 mg/kg (DRUG), Neihulizumab (DRUG).
Who is sponsoring clinical trial NCT04144036?
This trial is sponsored by Sameem M. Abedin, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04144036's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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