WithdrawnPhase 3

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

Stopped: Business decision

Japan0Started 2022-08-31

Plain-language summary

This clinical study aims to evaluate the safety and efficacy of repeated dosing of recombinant human parathyroid hormone (rhPTH\[1-84\]) in Japanese participants with chronic hypoparathyroidism for a 26-week period.

Who can participate

Age range

20 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. If not receiving thyroid hormone replacement therapy, the participant has a serum thyroid stimulating hormone (TSH) level within normal laboratory limits at screening.
. If receiving thyroid hormone replacement therapy, the dose must have been stable for at least 3 months prior to screening and serum TSH level within the reference range for the laboratory.
. Hypocalcemia (albumin-corrected serum calcium \<8.0 mg/dL) or
. Hypercalciuria (urine calcium \[mg/dL\]/creatinine \[mg/dL\] ratio \>0.4 or 24 hour urine calcium excretion \>7.5 millimoles (mmol) \[300 milligram {mg}\]/24 hours in men and \>6.25 millimoles (mmol) \[250 mg\]/24 hours in women) or,
. Symptoms of hypoparathyroidism.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Responders at Week 26

Timeframe: Week 26

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From start of study treatment up to 30 weeks

Trial details

NCT IDNCT03878953

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More Chronic Hypoparathyroidism trials