A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism

PHASE4CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

October 27, 2016

Primary Completion Date

December 20, 2019

Study Completion Date

December 20, 2019

Conditions
Chronic HypoparathyroidismHypoparathyroidism
Interventions
DRUG

rhPTH(1-84)

Participants will receive 25, 50, 75, and 100 microgram (mcg) of rhPTH(1-84) subcutaneous injection to the thigh via a multidose pen injector device once daily for 36 months. The dose will be individualized based on Albumin-corrected Serum Calcium (ACSC) and 24-hour calcium urinary excretion to achieve a serum calcium level in the lower half of the normal range.

Trial Locations (1)

10032

Columbia University Medical Center, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT02910466 - A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism | Biotech Hunter | Biotech Hunter