Back to resultsA Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary (REPEAT)
Primary Purpose
Hypoparathyroidism
Status
Completed
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
NPSP558
Sponsored by
About this trial
This is an interventional treatment trial for Hypoparathyroidism focused on measuring PTH 1-84, Hypoparathyroidism, NPSP558, Parathyroid Hormone 1-84
Eligibility 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
Sites / Locations
- Semmelweis University Medical School
- University of Pécs, School of Medicine
- University of Szeged
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NPSP558
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.
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
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Proportion of Patients Achieving the Primary Endpoint at Each Visit
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01455181
Brief Title
A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
Acronym
REPEAT
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 Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 19, 2011 (Actual)
Primary Completion Date
April 26, 2012 (Actual)
Study Completion Date
April 26, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoparathyroidism
Keywords
PTH 1-84, Hypoparathyroidism, NPSP558, Parathyroid Hormone 1-84
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPSP558
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NPSP558
Other Intervention Name(s)
REPEAT
Intervention Description
50, 75, 100 μg
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.
Description
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.
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
Time Frame
24 Weeks
Title
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Time Frame
24 Weeks
Title
Proportion of Patients Achieving the Primary Endpoint at Each Visit
Description
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.
Time Frame
24 Weeks
Title
Mean Change From Baseline in 24-hour Urine Calcium Excretion
Time Frame
24 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Semmelweis University Medical School
City
Budapest
Country
Hungary
Facility Name
University of Pécs, School of Medicine
City
Pécs
Country
Hungary
Facility Name
University of Szeged
City
Szeged
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
26684150
Citation
Lakatos P, Bajnok L, Lagast H, Valkusz Z. AN OPEN-LABEL EXTENSION STUDY OF PARATHYROID HORMONE RHPTH(1-84) IN ADULTS WITH HYPOPARATHYROIDISM. Endocr Pract. 2016 May;22(5):523-32. doi: 10.4158/EP15936.OR. Epub 2015 Dec 18.
Results Reference
result
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A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
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