Actively Recruiting
Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment
Led by Hospital Universitario Dr. Jose E. Gonzalez · Updated on 2025-04-03
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitario Dr. Jose E. Gonzalez
Lead Sponsor
M
Marisa Romero Martínez
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older.
- Any gender.
- Post-allogeneic hematopoietic cell transplantation (haploidentical or identical).
- Recently diagnosed acute graft-versus-host disease grades 2 to 4 requiring systemic steroids.
- Have not used steroids at 1 mg/kg/day or higher for more than 3 days in the last week.
- Willing to sign informed consent.
- Women of reproductive potential agree to use effective contraception or remain abstinent from study start until 30 days after.
- Men agree to use male condoms or remain abstinent from study start until 30 days after.
You will not qualify if you...
- Arterial or venous thrombosis within the past 3 months.
- History of thromboembolic disease needing full-dose anticoagulation.
- Active malignant disease.
- Uncontrolled infection.
- Chronic use of supplemental sex hormones (estrogen, progesterone, testosterone).
- Positive pregnancy test at initial evaluation.
- Unwillingness to use contraception or abstain to avoid pregnancy from study start until 30 days after in reproductive-age women or men.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
Research Team
C
Cesar H Gutierrez Aguirre, MD
CONTACT
D
David Gómez Almaguer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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