Tolerability Study of Xerecept® in Pediatric Patients

What Was Tested

This registered phase 1, phase 2 trial tested CRH (Corticotropin-Releasing Hormone).

It had 1 arm (groups): Xerecept (experimental).

All patients will receive hCRF (XERECEPT).

The registry classes the interventions as drug.

More on the Plan

Steroid-related side effects are much more severe in a pediatric population than they are in adults.

The side effects appear more quickly and are often apparent in as few as 14 days.

Although extensive studies have been performed with Xerecept® in adults, no studies have been performed with Xerecept® in pediatric subjects.

Who Took Part

The registry lists 15 actual participants took part.

It was open to people of any sex aged from 1 Year up to 18 years.

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

Examples of who could join: Have one or more steroid-associated side effects at Screening (See Appendix A1 for a list of qualifying events). Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver. Karnofsky/Lansky performance status ≥ 40. Life expectancy of at least 6 months. Female subjects must not be pregnant or breast-feeding and, if of childbearing potential, must use adequate methods of contraception during the study.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: evidence of previous or current overt renal, hepatic or pulmonary diseases or active uncontrolled infection; subject and/or parent/guardian is unwilling or unable to comply with this protocol; subject has a known history of allergy or intolerance to hcrf or other ingredients in the xerecept® solution (e.g., methionine, mannitol).

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the CRH (Corticotropin-Releasing Hormone) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-06 with completion listed for 2012-10.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Incidence and severity of specified Steroid-Related Side Effects, Number of patients with adverse events, Change from baseline in clinical chemistry, hematology and urinalysis measures and PedsQL™ Quality of Life Inventory Scores.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of CRH (Corticotropin-Releasing Hormone) in 15 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the CRH (Corticotropin-Releasing Hormone) compound page, all human trials.