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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 (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 13, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypoparathyroidism
Intervention Drug: NPSP558
Enrollment 24
Recruitment Details 24 Subjects were enrolled between 8/2011 to 5/2012 at 3 Clinical sites in Hungary.
Pre-assignment Details Subjects 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 met inclusion/exclusion criteria for REPLACE.
Arm/Group Title NPSP558
Hide Arm/Group Description NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title NPSP558
Hide Arm/Group Description NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants
< 45 years 6
45 to 64 years 17
≥ 65 years 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
21
  87.5%
Male
3
  12.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
24
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
24
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Hungary Number Analyzed 24 participants
24
1.Primary Outcome
Title Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NPSP558
Hide Arm/Group Description:
NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
Overall Number of Participants Analyzed 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.0
(53.3 to 90.2)
2.Secondary Outcome
Title Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
Hide Description [Not Specified]
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NPSP558
Hide Arm/Group Description:
NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: percentage of change
Week 2 -47.08  (31.566)
Week 4 -80.38  (16.688)
Week 8 -96.70  (7.865)
Week 16 -96.18  (11.521)
Week 24 -97.92  (10.206)
3.Secondary Outcome
Title Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Hide Description [Not Specified]
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.
Arm/Group Title NPSP558
Hide Arm/Group Description:
NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: percentage of change
Week 2 -8.3  (36.20)
Week 4 -46.4  (35.57)
Week 8 -71.5  (33.14)
Week 16 -71.7  (38.60)
Week 24 -76.0  (40.48)
4.Secondary Outcome
Title Proportion of Patients Achieving the Primary Endpoint at Each Visit
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement .
Arm/Group Title NPSP558
Hide Arm/Group Description:
NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 20.8
Week 4 50.0
Week 8 70.8
Week 16 83.3
Week 24 83.3
5.Secondary Outcome
Title Mean Change From Baseline in 24-hour Urine Calcium Excretion
Hide Description [Not Specified]
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.
Arm/Group Title NPSP558
Hide Arm/Group Description:
NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mg/24 hour
Week 8 -64.58  (188.42)
Week 24 -51.53  (183.41)
Time Frame 24 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NPSP558
Hide Arm/Group Description NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
All-Cause Mortality
NPSP558
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NPSP558
Affected / at Risk (%) # Events
Total   0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NPSP558
Affected / at Risk (%) # Events
Total   22/24 (91.67%)    
Gastrointestinal disorders   
Hypoaesthesia oral  1  3/24 (12.50%)  4
Abdominal pain upper  1  2/24 (8.33%)  3
Nausea  1  2/24 (8.33%)  2
General disorders   
Fatigue  1  4/24 (16.67%)  6
Investigations   
Vitamin D decreased  1  6/24 (25.00%)  6
Metabolism and nutrition disorders   
Hypercalcaemia  1  5/24 (20.83%)  7
Hypocalcaemia  1  4/24 (16.67%)  4
Tetany  1  3/24 (12.50%)  3
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  6/24 (25.00%)  8
Arthralgia  1  3/24 (12.50%)  3
Pain in extremity  1  2/24 (8.33%)  2
Nervous system disorders   
Hypoaesthesia  1  12/24 (50.00%)  23
Headache  1  4/24 (16.67%)  5
Paraesthesia  1  2/24 (8.33%)  3
Renal and urinary disorders   
Polyuria  1  2/24 (8.33%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  2/24 (8.33%)  2
Skin and subcutaneous tissue disorders   
Hypoaesthesia facial  1  2/24 (8.33%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Executive Director, Clinical Development
Organization: NPS Pharmaceuticals
Phone: +1 908-450-5300
EMail: info@npsp.com
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01455181     History of Changes
Other Study ID Numbers: PAR-C10-009
First Submitted: September 15, 2011
First Posted: October 19, 2011
Results First Submitted: February 20, 2015
Results First Posted: March 6, 2015
Last Update Posted: December 13, 2018