Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment
ConditionAcute Graft Versus Host Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario Dr. Jose E. Gonzalez
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Arterial or venous thrombosis in the past 3 months.
History of thromboembolic disease requiring full-dose anticoagulation.
Diagnosis of active malignant disease.
Uncontrolled infection.
Trial design
Treatments tested in this trial
- Human chorionic gonadotropin (hCG)
- Prednisone
- Dexamethasone
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Lead sponsor
Marisa Romero Martínez
Collaborator
Dr. José Carlos Jaime Perez
Collaborator
Dr. David Gómez Almaguer
Collaborator
Dra. Consuelo Mancias Guerra
Collaborator
Dr. Andrés Gómez de León
Collaborator
Dra. Olga Graciela Catú Rodríguez
Collaborator
Dra. Perla Colunga Pedraza
Collaborator
Dra. Michelle Morcos Sandino
Collaborator
Source ClinicalTrials.gov