NCT03878953

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

A Phase 3, Open-label Clinical Study of rhPTH(1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	rhPTH(1-84)	Participants will receive a SC injection of initial dose of 50 mcg of rhPTH(1-84) once daily (QD) in the thigh (alternate thigh every day). If albumin-corrected serum calcium (ACSC; \[mg/dL\] = serum calcium \[mg/dL\] +0.8\*\[4-serum albumin (g/dL)\]) is \>2.25 mmol/L (\>9.0 mg/dL), a starting dose of 25 mcg will be considered. At 4 week intervals the rhPTH(1-84) dose may be increased in 25 mcg increments to a maximal dose of 100 mcg SC QD. At any time during the study as needed for safety reasons, rhPTH(1-84) doses may be decreased in 25 mcg decrements to a minimum of 25 mcg QD. If the ACSC is \>2.97 mmol/L (\>11.9 mg/dL), then the investigational product should be stopped until the calcium level is corrected.

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2019-03-18
• Last updated: 2022-10-10

Locations

10 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study