Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test hCG (human chorionic gonadotropin).

It had 20 arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 53 actual participants took part.

It was open to people of any sex aged up to 76 years.

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

Examples of who could join: Acute graft versus host disease (GVHD) fitting one of the following categories:. Steroid-Refractory aGVHD (ARM 2): Pediatric or adult (ages 12-76 years) HCT recipient with grade II-IV steroid refractory or steroid-dependent acute GVHD, defined as any one of the following:. Adequate organ function at study enrollment defined as:. Renal: 1.73m2Serum creatinine ≤2.5x upper limit of normal (ULN). Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds).

The full record lists 11 inclusion and 11 exclusion criteria; among the exclusions: progressive malignancy; diagnosis of a hormone responsive malignancy; uncontrolled infection at initiation of protocol treatment.

How the Study Was Run

Design: non-randomized, sequential and open-label.

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

It started in 2016-03 with completion listed for 2021-05.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Phase I: MTD (USP hCG) (time frame: Day 14 after initiation of protocol therapy). Phase I: MTD (pg EGF/m^2) (time frame: Day 14 after initiation of protocol therapy). Number of Patients With Complete Response (time frame: Day 28 after initiation of protocol therapy).

It also tracked 5 secondary outcomes, for example Number of Participants With Adverse Events as a Measure of Safety and Feasibility of hCG Supplementation With Pregnyl®, Number of Participants With Incidence of aGVHD Flare, Number of Participants With Incidence of aGVHD Flare, Rate of Participants Who Fail Treatment at Day 28 and Rate of Participants Who Fail Treatment at Day 56.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of hCG (human chorionic gonadotropin) in 53 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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