A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary (REPEAT)
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ClinicalTrials.gov Identifier: NCT01455181 |
Recruitment Status
:
Completed
First Posted
: October 19, 2011
Results First Posted
: March 6, 2015
Last Update Posted
: December 8, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoparathyroidism | Drug: NPSP558 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A 6-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 |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: NPSP558 |
Drug: NPSP558
50, 75, 100 μg
Other Name: REPEAT
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- Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. [ Time Frame: 24 Weeks ]A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
- Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit [ Time Frame: 24 Weeks ]
- Mean Percentage Changes From Baseline in Oral Calcium at Each Visit [ Time Frame: 24 Weeks ]
- Proportion of Patients Achieving the Primary Endpoint at Each Visit [ Time Frame: 24 Weeks ]A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
- Mean Change From Baseline in 24-hour Urine Calcium Excretion [ Time Frame: 24 Weeks ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who meet all the following inclusion criteria can be enrolled into this study:
- Signed and dated informed consent form (ICF) before any study-related procedures are performed
- Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study, OR Enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE
- Able to perform daily SC self-injections of study medication (or have a designee perform injection) via a multidose injection pen into the thigh
- Willingness and ability to understand and comply with the protocol
- Women who are: (1) postmenopausal defined as 12 months amenorrhea with appropriate serum follicle stimulating hormone (FSH) levels (> 40 IU/L); (2) surgically sterilized; OR (3) of childbearing potential with a negative pregnancy test at screening and who consent to use two acceptable methods of contraception for the duration of the study, with pregnancy testing at every scheduled visit during the treatment period . Female partners (who are of childbearing potential) of male study patients must also use acceptable forms of contraception during their partner's participation
Exclusion Criteria:
Patients who meet any of the following exclusion criteria at baseline (Visit 1) are not eligible for enrollment in this study:
- Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of NPSP558
- Any disease or condition in the opinion of the investigator that has a high probability of precluding the patient from completing the study or where the patient cannot or will not appropriately comply with study requirements
- Pregnant or lactating woman

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455181
Hungary | |
Semmelweis University Medical School | |
Budapest, Hungary | |
University of Pécs, School of Medicine | |
Pécs, Hungary | |
University of Szeged | |
Szeged, Hungary |
Study Director: | Hjalmar Lagast, M.D. | NPS Pharma |
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT01455181 History of Changes |
Other Study ID Numbers: |
PAR-C10-009 |
First Posted: | October 19, 2011 Key Record Dates |
Results First Posted: | March 6, 2015 |
Last Update Posted: | December 8, 2015 |
Last Verified: | March 2015 |
Keywords provided by Shire:
Hypoparathyroidism NPSP558 Parathyroid Hormone 1-84 PTH 1-84 |
Additional relevant MeSH terms:
Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases |