Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment

Launched by HOSPITAL UNIVERSITARIO DR. JOSE E. GONZALEZ · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for acute graft-versus-host disease (GVHD), a serious condition that can occur after a type of stem cell transplant. Currently, the standard treatment involves corticosteroids, but these can be costly and not always effective. Researchers are exploring whether human chorionic gonadotropin, a hormone, can help improve outcomes for patients with this condition, as it has shown promise in some previous cases.

To participate in the trial, individuals must be at least 18 years old, have recently developed acute GVHD that requires steroid treatment, and have not been on steroids for more than three days prior to joining the study. Both men and women are eligible, but women of childbearing age must agree to use contraception during the trial. Participants can expect to receive the hormone treatment and will be monitored closely by the research team. This trial is currently recruiting participants, and those who qualify may have the opportunity to contribute to important research that could improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.