A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary - Full Text View

Purpose

This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.

Condition	Intervention	Phase
Hypoparathyroidism	Drug: NPSP558	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Hypoparathyroidism

U.S. FDA Resources

Further study details as provided by Shire:

Primary Outcome Measures:

Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Proportion of Patients Achieving the Primary Endpoint at Each Visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]


Enrollment:	24
Study Start Date:	August 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NPSP558	Drug: NPSP558 50, 75, 100 μg Other Name: REPEAT

Detailed Description:

Subjects either must have previously completed NPSP558 Study CL1-11-040 (REPLACE) including 24 weeks of active therapy and 4 weeks of follow-up to Week 28 prior to enrolling in this study or have enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455181

Locations


Hungary
Semmelweis University Medical School
Budapest, Hungary
University of Pécs, School of Medicine
Pécs, Hungary
University of Szeged
Szeged, Hungary

Sponsors and Collaborators

Shire

Investigators


Study Director:	Hjalmar Lagast, M.D.	NPS Pharma

More Information


Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01455181 History of Changes
Other Study ID Numbers:	PAR-C10-009
Study First Received:	September 15, 2011
Results First Received:	February 20, 2015
Last Updated:	November 10, 2015
Health Authority:	Hungary: Scientific and Medical Research Council Ethics Committee

Keywords provided by Shire:


Hypoparathyroidism NPSP558 Parathyroid Hormone 1-84 PTH 1-84

Additional relevant MeSH terms:


Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on September 23, 2016

A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary (REPEAT)