Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NPS Pharma
ClinicalTrials.gov Identifier:
NCT01268098
First received: December 28, 2010
Last updated: March 10, 2015
Last verified: March 2015
Results First Received: February 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypoparathyroidism
Intervention: Drug: NPSP558

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
42 Subjects enrolled between 2/2011 and 9/2011 at 11 sites in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who completed 24 wks of treatment and 4 wks follow-up in the REPLACE Study (NCT00732615) or received 2 single doses in Phase I Study C09-002 followed by a 4-wk washout, or enrolled in the REPLACE Study and entered into the optimization phase, but were not randomized due to the close of randomization; or were new to the NPSP558 program.

Reporting Groups
  Description
NPSP558 - 25 µg Dose NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily.
NPSP558 - 50 µg Dose NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily.

Participant Flow:   Overall Study
    NPSP558 - 25 µg Dose     NPSP558 - 50 µg Dose  
STARTED     19     23  
COMPLETED     18     23  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  



  Baseline Characteristics
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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 - 25 µg Dose NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
NPSP558 - 50 µg Dose NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
Total Total of all reporting groups

Baseline Measures
    NPSP558 - 25 µg Dose     NPSP558 - 50 µg Dose     Total  
Number of Participants  
[units: participants]
  19     23     42  
Age, Customized  
[units: participants]
     
< 45 years     6     8     14  
45 to 64 years     10     15     25  
>/= 65 years     3     0     3  
Gender  
[units: participants]
     
Female     16     19     35  
Male     3     4     7  
Race/Ethnicity, Customized  
[units: participants]
     
White     17     22     39  
Asian     1     1     2  
Native Hawaiian/Pacific Islander     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     19     23     42  



  Outcome Measures
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1.  Primary:   Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.   [ Time Frame: 8 Weeks ]

2.  Secondary:   The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.   [ Time Frame: 8 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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


No publications provided


Responsible Party: NPS Pharma
ClinicalTrials.gov Identifier: NCT01268098     History of Changes
Other Study ID Numbers: PAR-C10-007
Study First Received: December 28, 2010
Results First Received: February 20, 2015
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration