Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment

What Was Tested

The trial (phase 2) is built around hCG (human chorionic gonadotropin).

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.

It had two arms (groups): Study group (active comparator) and Control group (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged 18 years or older. 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. Willing to participate in the study by signing informed consent.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: arterial or venous thrombosis in the past 3 months; diagnosis of active malignant disease; uncontrolled infection.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-02-01 with completion listed for 2026-01-31.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Measurement of GVHD response (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of hCG (human chorionic gonadotropin) in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.