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A 12-Month 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):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01297309
First received: February 11, 2011
Last updated: April 15, 2014
Last verified: April 2014

February 11, 2011
April 15, 2014
April 2011
December 2014   (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 ] [ Designated as safety issue: Yes ]
  • A reduction in oral calcitriol to ≤ 0.25 μg [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01297309 on ClinicalTrials.gov Archive Site
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A 12-Month 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 12-Month 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
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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
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
December 2014
December 2014   (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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01297309
PAR-C10-008
No
NPS Pharmaceuticals
NPS Pharmaceuticals
Not Provided
Study Director: Hjalmar Lagast, M.D. NPS Pharmaceuticals
NPS Pharmaceuticals
April 2014

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