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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: February 1, 2017
Last verified: February 2017

February 11, 2011
February 1, 2017
April 2011
January 2018   (Final data collection date for primary outcome measure)
  • Demonstrate the long-term safety of subcutaneous (SC) NPSP558 (rhPTH[1-84]) [ Time Frame: Up to 80 months of treatment, 4 weeks of follow-up ]
  • Demonstrate the long-term tolerability of subcutaneous (SC) NPSP558 (rhPTH[1-84]) [ Time Frame: up to 80 months of treatment, 4 weeks of follow-up ]
  • 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 ]
Complete list of historical versions of study NCT01297309 on ClinicalTrials.gov Archive Site
  • Evaluate the impact of different preparations of calcium on the response to rhPTH[1-84] replacement therapy [ Time Frame: Up to 80 months of treatment, 4 weeks of follow-up ]
  • Demonstrate that dosing with rhPTH[1-84] across a dose range of 25 to 100 μg SC can be implemented in a safe and effective manner and can be maintained throughout long-term treatment [ Time Frame: Up to 80 months of treatment, 4 weeks of follow-up ]
  • Evaluate the impact of calcium-sparing diuretics on serum and urinary calcium [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ]
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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 long-term, 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 up to 80 months, 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: No masking
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
50
January 2018
January 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
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
Not Provided
Not Provided
Not Provided
Shire
Shire
Not Provided
Study Director: Shire Physician Shire
Shire
February 2017

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