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
1 other identifier
interventional
20
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedFirst Submitted
Initial submission to the registry
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedApril 3, 2025
March 1, 2025
12 months
March 25, 2025
March 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of GVHD response
The primary outcome measure for this study is the effectiveness of human chorionic gonadotropin (hCG) when combined with steroids in the treatment of acute graft-versus-host disease (aGVHD) in patients with allogeneic hematopoietic cell transplantation (allo-HCT). This could be assessed using clinical criteria such as improvement in skin, liver, gastrointestinal symptoms, and overall patient condition, evaluated at specified time points (e.g., day 7, day 14, and at the end of the treatment regimen).
1 year
Study Arms (2)
Study group
ACTIVE COMPARATOROral prednisone 1 mg/kg/day for 14 days or IV dexamethasone 0.15 mg/kg/day for 14 days + human chorionic gonadotropin 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.
Control group
ACTIVE COMPARATOROral prednisone 1 mg/kg/day for 14 days or IV dexamethasone 0.15 mg/kg/day for 14 days.
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitario Dr. Jose E. Gonzalezlead
- Marisa Romero Martínezcollaborator
- Dr. José Carlos Jaime Perezcollaborator
- Dr. David Gómez Almaguercollaborator
- Dra. Consuelo Mancias Guerracollaborator
- Dr. Andrés Gómez de Leóncollaborator
- Dra. Olga Graciela Catú Rodríguezcollaborator
- Dra. Perla Colunga Pedrazacollaborator
- Dra. Michelle Morcos Sandinocollaborator
Study Sites (1)
Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460, Mexico
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 25, 2025
First Posted
April 1, 2025
Study Start
February 1, 2025
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
April 3, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share