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:
NPS Pharmaceuticals
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01297309
First received: February 11, 2011
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
This study is a 12-month, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypoparathyroidism |
Drug: NPSP558 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
MedlinePlus related topics:
Calcium
Drug Information available for:
Parathyroid Hormone
U.S. FDA Resources
Further study details as provided by NPS Pharmaceuticals:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: NPSP558 |
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Hypoparathyroidism ≥ 18 months
- Adult males and females ages 18 to 85 years of age
- Able to perform daily SC self-injections of study medication
- Previously completed a NPSP558 study
- Women of childbearing potential need to use two methods of contraception.
Exclusion Criteria:
- 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
- Pregnant or lactating woman.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297309
Locations
| United States, California | |
| Advance Medical Research LLC | |
| Lakewood, California, United States, 90712 | |
| United States, Florida | |
| Mayo Clinic Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Michigan Bone & Mineral Clinic PC | |
| Detroit, Michigan, United States, 48236 | |
| United States, Minnesota | |
| Mayo Clinic Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| University Physicians Group | |
| Staten Island, New York, United States, 10301 | |
| United States, North Carolina | |
| Physician East PA | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| University of Cincinnati Bone Health and Osteoporosis Center | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Cetero Research DGD Research Inc. | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| The Vancouver Clinic | |
| Vancouver, Washington, United States, 98664 | |
Sponsors and Collaborators
NPS Pharmaceuticals
Investigators
| Study Director: | Hjalmar Lagast, M.D. | NPS Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | NPS Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01297309 History of Changes |
| Other Study ID Numbers: | PAR-C10-008 |
| Study First Received: | February 11, 2011 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NPS Pharmaceuticals:
|
Hypoparathyroidism NPSP558 Parathyroid Hormone 1-84 PTH 1-84 |
Additional relevant MeSH terms:
|
Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013