A Phase 2 interventional study of Human chorionic gonadotropin (hCG) and Prednisone in Acute Graft Versus Host Disease, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Phase 2, Interventional, and Treatment
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.
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, to receive conventional treatment with steroids (prednisone 1 mg/kg/day for 14 days) or combined treatment (hCG 2500 IU, IM + prednisone 1 mg/kg/day for 14 days).
804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.
This study's planned enrollment of 20 is below the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral 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.
Drug: Human chorionic gonadotropin (hCG) · Drug: Prednisone · Drug: Dexamethasone
Oral prednisone 1 mg/kg/day for 14 days or IV dexamethasone 0.15 mg/kg/day for 14 days.
Drug: Prednisone · Drug: Dexamethasone
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.
Oral prednisone 1 mg/kg/day for 14 days
IV dexamethasone 0.15 mg/kg/day for 14 days
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).
Time frame: 1 year
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for Jan 2026, 11 months after the start.
Of 85 non-industry phase 2 interventional studies under Graft vs Host Disease, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 116. This study's planned 11 months is below that.
Counting every sponsor, half of 102 studies reached it within 51 months; a quarter within 29 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Chorionic Gonadotropin
Hospital Universitario Dr. Jose E. Gonzalez