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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01297309
First received: February 11, 2011
Last updated: January 13, 2017
Last verified: January 2017

February 11, 2011
January 13, 2017
April 2011
January 2018   (Final data collection date for primary outcome measure)
  • A reduction in oral calcium or an oral calcium dose of ≤ 500 mg [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ]
  • A reduction in oral calcitriol to ≤ 0.25 μg [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ]
  • An albumin-corrected total serum calcium concentration that is normalized or maintained compared to the baseline value (≥7.5 mg/dL) and ULN [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ]
Same as current
Complete list of historical versions of study NCT01297309 on ClinicalTrials.gov Archive Site
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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)
A Long-term 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)
This study is a 12-month, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for 52 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypoparathyroidism
Drug: NPSP558
All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.
Other Name: RACE
Experimental: NPSP558
titration of 25, 50, 75 or 100 μg
Intervention: Drug: NPSP558
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
January 2018
January 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosis of Hypoparathyroidism ≥ 18 months
  2. Adult males and females ages 18 to 85 years of age
  3. Able to perform daily SC self-injections of study medication
  4. Previously completed a NPSP558 study
  5. Women of childbearing potential need to use two methods of contraception.

Exclusion Criteria:

  1. Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of PTH 1-84 and/or completing this trial
  2. Pregnant or lactating woman.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01297309
PAR-C10-008
No
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Shire
Shire
Not Provided
Study Director: Hjalmar Lagast, M.D. Shire
Shire
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP