Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment
NCT06904599 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-04-03
Summary
Graft-versus-host disease is a complication of allogeneic hematopoietic cell transplantation with high morbidity and mortality. The standard treatment is corticosteroids, and based on the response within 3 to 7 days, a second-line therapy is added, which is expensive and not easily accessible. The administration of human chorionic gonadotropin has shown therapeutic effectiveness in 50% of patients in reported clinical cases.
Conditions
- Acute Graft Versus Host Disease
Interventions
- DRUG
-
Human chorionic gonadotropin (hCG)
2500 IU intramuscular on days 1, 3, and 5 of the protocol. Patients who have at least a partial response by day 7 will receive 3 weekly doses for an additional 4 weeks.
- DRUG
-
Oral prednisone 1 mg/kg/day for 14 days
- DRUG
-
IV dexamethasone 0.15 mg/kg/day for 14 days
Sponsors & Collaborators
-
Marisa Romero Martínez
collaborator UNKNOWN -
Dr. José Carlos Jaime Perez
collaborator UNKNOWN -
Dr. David Gómez Almaguer
collaborator UNKNOWN -
Dra. Consuelo Mancias Guerra
collaborator UNKNOWN -
Dr. Andrés Gómez de León
collaborator UNKNOWN -
Dra. Olga Graciela Catú Rodríguez
collaborator UNKNOWN -
Dra. Perla Colunga Pedraza
collaborator UNKNOWN -
Dra. Michelle Morcos Sandino
collaborator UNKNOWN -
Hospital Universitario Dr. Jose E. Gonzalez
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2026-01-31
- Completion
- 2026-01-31
Countries
- Mexico
Study Locations
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