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NCT04095858 · ClinicalTrials.gov registry record · Phase 3
Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)
A Phase 3 study, sponsored by Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Terminated
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
NCT04095858 is a Phase 3 study that was terminated before completion, run by Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 11 participants.
The verdict
NCT04095858, a Phase 3 study, was terminated before completion, sponsored by Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
Study Summary
The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate. The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa/tacrolimus / methotrexate (efprezimod alfa/Tac/MTX) versus placebo/tacrolimus / methotrexate (placebo/Tac/MTX) in the setting of myeloablative conditioning (MAC), matched unrelated donor (MUD) allogeneic hematopoietic stem cell transplantation in participants with acute leukemia (AML/ALL) or myelodysplastic syndrome (MDS). The study agent, efprezimod alfa, will be administered through IV infusion on days -1, 14, and 28 at the dose of 480mg, 240 mg and 240mg, respectively. The placebo will be 100 ml normal saline intravenous (IV) solution.
Interventions
- DRUG Placebo
- DRUG Tacrolimus
- DRUG Methotrexate
- DRUG Efprezimod alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-01-05 |
| Est. Completion | 2021-11-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04095858
The ClinicalTrials.gov registry entry for NCT04095858 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04095858 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04095858 about?
NCT04095858 is a clinical study titled "Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)". The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate. The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa/tacrolimus / methotre...
What is the current status of trial NCT04095858?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2021-01-05. Estimated completion is 2021-11-05.
What interventions are being tested in trial NCT04095858?
The interventions under investigation include: Placebo (DRUG), Tacrolimus (DRUG), Methotrexate (DRUG), Efprezimod alfa (DRUG).
Who is sponsoring clinical trial NCT04095858?
This trial is sponsored by Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 5 total clinical trials registered on ClinicalTrials.gov.
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