A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

Completed · Phase 3

Conditions studied: Hypoparathyroidism

In brief

This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.

Key facts

Study ID

NCT01297309

Run by

Shire

People needed

51

Starts

2011-04-06

Expected to finish

2018-06-08

Last updated by the study team

2021-05-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously completed the rhPTH[1-84] RELAY study (8 weeks of active therapy) and/or previously completed the rhPTH[1-84] REPLACE study (Visit 18).
• Able to perform daily SC self-injections of study medication (or have a designee perform injection).
• Women who are (1) postmenopausal; (2) surgically sterilized; or, (3) of childbearing potential with a negative pregnancy test and who consent to use two acceptable methods of contraception for the duration of the study.
• Males who have female partners of childbearing potential must use two acceptable forms of contraception for the duration of the study.
• Serum creatinine <1.5 mg/dL at enrollment.
• Total serum calcium less than or equal to upper limit of normal (ULN) based on local laboratory result prior to enrollment.
• Serum 25 hydroxy (OH) vitamin D less than or equal to 1.5 times the ULN within approximately 16 weeks prior to enrollment.

You may not qualify if…

• Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of parathyroid hormone (PTH).
• Pregnant or lactating women.
• Any disease or condition which has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements.

Where it is running

• Advance Medical Research LLC — Lakewood, California, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Michigan Bone & Mineral Clinic PC — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• University Physicians Group — Staten Island, New York, United States
• Physician East PA — Greenville, North Carolina, United States
• University of Cincinnati Bone Health and Osteoporosis Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Cetero Research DGD Research Inc. — San Antonio, Texas, United States
• The Vancouver Clinic — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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