A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism

What Was Tested

In this phase 3 trial, researchers set out to test Parathyroid Hormone (PTH 1-84).

It had 1 arm (groups): rhPTH(1-84) (experimental).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 20 years up to 85 years.

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

Examples of who could join: The participant has signed and dated the informed consent form. The participant is an adult male or female 20 to 85 years of age inclusive. The participant is living in Japan and is Japanese; in this case, Japanese is defined as having been born in Japan, with Japanese parents, and Japanese maternal and paternal grandparents. Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol. The participant meets 1 of the following criteria:.

The full record lists 18 inclusion and 16 exclusion criteria; among the exclusions: the participant and/or legally authorized representative(s) is unable to understand the nature, scope, and possible consequences of the study; the participant has a known history of hypoparathyroidism resulting from an activating mutation in the casr gene or impaired responsiveness to pth (pseudohypoparathyroidism); the participant is taking prohibited medications (listed below) or other drugs known to influence calcium and bone metabolism during their respective prohibited periods.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Parathyroid Hormone (PTH 1-84) 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 2022-08-31 with completion listed for 2023-05-31.

It ran at 10 sites in Japan (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Responders at Week 26 (time frame: Week 26). Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From start of study treatment up to 30 weeks).

It also tracked 2 secondary outcomes, for example Change From Baseline in Serum Phosphate Level and Change From Baseline in Urine Calcium Level.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Parathyroid Hormone (PTH 1-84) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.