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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01455181
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : March 6, 2015
Last Update Posted : December 8, 2015
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
24 Subjects were enrolled between 8/2011 to 5/2012 at 3 Clinical sites in Hungary.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
NPSP558 NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.

Participant Flow:   Overall Study
    NPSP558
STARTED   24 
COMPLETED   24 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NPSP558 NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.

Baseline Measures
   NPSP558 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age, Customized 
[Units: Participants]
 
< 45 years   6 
45 to 64 years   17 
≥ 65 years   1 
Gender 
[Units: Participants]
 
Female   21 
Male   3 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   24 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   24 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
Hungary   24 


  Outcome Measures

1.  Primary:   Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.   [ Time Frame: 24 Weeks ]

2.  Secondary:   Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit   [ Time Frame: 24 Weeks ]

3.  Secondary:   Mean Percentage Changes From Baseline in Oral Calcium at Each Visit   [ Time Frame: 24 Weeks ]

4.  Secondary:   Proportion of Patients Achieving the Primary Endpoint at Each Visit   [ Time Frame: 24 Weeks ]

5.  Secondary:   Mean Change From Baseline in 24-hour Urine Calcium Excretion   [ Time Frame: 24 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Executive Director, Clinical Development
Organization: NPS Pharmaceuticals
phone: +1 908-450-5300
e-mail: 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 8, 2015