Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment

Recruiting now · Phase 2

Conditions studied: Acute Graft Versus Host Disease

In brief

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.

Key facts

Study ID

NCT06904599

Run by

Hospital Universitario Dr. Jose E. Gonzalez

People needed

20

Starts

2025-02-01

Expected to finish

2026-01-31

Last updated by the study team

2025-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Universidad Autónoma de Nuevo León — Monterrey, Nuevo León, Mexico (enrolling)

Full record on ClinicalTrials.gov

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