Status:
RECRUITING
Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Collaborating Sponsors:
Marisa Romero Martínez
Dr. José Carlos Jaime Perez
Conditions:
Acute Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wit...
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...
Eligibility Criteria
Inclusion
- Aged 18 years or older.
- Any gender.
- Post-allogeneic transplantation status (haploidentical or identical) of hematopoietic cells.
- Presenting recently onset aGVHD, grades 2 to 4, and requiring systemic steroid use as determined by the treating physician.
- Have not received steroids (Prednisone ≥1 mg/kg/day or equivalent dose of another steroid) for more than 3 days in the last week.
- Willing to participate in the study by signing informed consent.
- If the subject is female and has the potential to procreate (a woman is considered fertile from menarche to postmenopausal stage or after undergoing a permanent contraceptive method), she agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: oral hormonal contraception, intrauterine device, barrier methods (diaphragm, male or female condom, and foam, sponge, or spermicide film), or agrees to remain abstinent. Women who have been postmenopausal for more than a year, undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy are not considered to have reproductive potential.
- If the subject is male, he agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: male condom, or remain abstinent.
Exclusion
- Arterial or venous thrombosis in the past 3 months.
- History of thromboembolic disease requiring full-dose anticoagulation.
- Diagnosis of active malignant disease.
- Uncontrolled infection.
- Chronic use of supplemental therapy with sex hormones (estrogen, progesterone, and/or testosterone).
- Women with a positive pregnancy test at the time of the initial evaluation.
- Women or men of reproductive age who are unwilling to take appropriate precautions to avoid an unwanted pregnancy from the start of the protocol until 30 days after the protocol.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06904599
Start Date
February 1 2025
End Date
January 31 2026
Last Update
April 3 2025
Active Locations (1)
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1
Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, Mexico, 64460