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

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

August 31, 2022

Primary Completion Date

May 31, 2023

Study Completion Date

May 31, 2023

Conditions
Chronic Hypoparathyroidism
Interventions
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.

Trial Locations (10)

470-1192

Fujita Health University Hospital, Toyoake-shi

807-8556

University of Occupational and Environmental Health Japan, Kitakyushu-shi

545-8586

Osaka City University Hospital, Osaka

693-8501

Shimane University Hospital, Izumo-shi

770-8503

Tokushima University Hospital, Tokushima

113-8655

University of Tokyo Hospital, Bunkyō City

135-8550

The Cancer Institute Hospital of JFCR, Kōtoku

105-8470

Toranomon Hospital, Minatoku

160-8582

Keio University Hospital, Shinjuku-ku

162-8666

Tokyo Women's Medical University Hospital, Shinjuku-ku

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY