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NCT03878953
A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism
Phase 3 trial testing rhPTH(1-84) in Chronic Hypoparathyroidism. Withdrawn.
31 May 2023
Quick facts
| Lead sponsor | Shire |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 31 August 2022 |
| Primary completion | 31 May 2023 |
| Estimated completion | 31 May 2023 |
| Sites | 10 locations across Japan |
Drugs / interventions tested
- rhPTH(1-84)
Conditions studied
- Chronic Hypoparathyroidism — all drugs for Chronic Hypoparathyroidism →
Sponsor
Shire — full company profile →
Who can join
Adults 20 to 85, any sex, with Chronic Hypoparathyroidism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03878953
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of rhPTH(1-84)
Trials testing the same drug.
- NCT05137730 — A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to F · Phase 1 · completed
- NCT03364738 — Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism · Phase 3 · terminated
- NCT03150108 — Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects · Phase 1 · completed
- NCT02910466 — A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism · Phase 4 · completed
Other recruiting trials for Chronic Hypoparathyroidism
Currently open trials in the same condition.
- NCT05778071 — Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism · Phase 3 · active not recruiting
Other Shire trials
Trials by the same sponsor.
- NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
- NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
- NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
- NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn
- NCT04636502 — Retrospective, Observational Chart Review Study Conducted in Poland to Document the Management and Clinical Outcome of C · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03878953 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shire
- Last refreshed: 10 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03878953.
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