NCT06904599

Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment

Evaluation of Human Chorionic Gonadotropin for the Treatment of Acute Graft-versus-host Disease in Patients With Allogeneic Hematopoietic Cell Transplantation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will include 20 patients with recent-onset allogeneic hematopoietic cell transplantation and GVHD who attend the Hematology Service at the University Hospital and meet the inclusion criteria, to receive conventional treatment with steroids (prednisone 1 mg/kg/day for 14 days) or combined treatment (hCG 2500 IU, IM + prednisone 1 mg/kg/day for 14 days).

Conditions

• Acute Graft Versus Host Disease

Interventions

Type	Name	Description
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	Prednisone	Oral prednisone 1 mg/kg/day for 14 days
DRUG	Dexamethasone	IV dexamethasone 0.15 mg/kg/day for 14 days

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-04-01
• Last updated: 2025-04-03

Locations

1 site across 1 country: Mexico