Clinical Trial: A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism

Brief Summary: This is an observational, international, open label, pilot study to evaluate the safety, tolerability and efficacy of an oral PTH (1-34) preparation produced by Entera Bio in adult hypoparathyroid volunteers.

Detailed Summary:
Sponsor: Entera Bio Ltd.

Current Primary Outcome:

  • Number of participants with adverse events [ Time Frame: up to 17 weeks ]
    safety will be measured by monitoring and recording adverse events related to hyper- and hypocalcemia
  • Reduction in use of exogenous calcium supplement and/or alpha D3 supplement [ Time Frame: up to 17 weeks ]
  • Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events [ Time Frame: up to 17 weeks ]
  • Plasma calcium levels [ Time Frame: at baseline and 60 minutes post-dose ]
  • Peak Plasma Concentration (Cmax)of treatment [ Time Frame: at baseline and time-points post-dose ]
    To study the pharmacokinetic profile of PTH absorption


Original Primary Outcome:

  • Number of participants with adverse events [ Time Frame: up to 17 weeks ]
    safety will be measured by monitoring and recording adverse events related to hyper- and hypocalcemia
  • Reduction in use of exogenous calcium supplement and/or alpha D3 supplement [ Time Frame: up to 17 weeks ]
  • Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events [ Time Frame: up to 17 weeks ]
  • Plasma calcium levels [ Time Frame: at baseline and 60 minutes post-dose ]
  • Peak Plasma Concentration (Cmax)of treatment [ Time Frame: at baseline and time-points 10, 15, 20, 30, 45, 60, 90, and 180 post-dose ]
    To study the pharmacokinetic profile of PTH absorption


Current Secondary Outcome:

  • The volunteers' compliance to treatment [ Time Frame: up to 17 weeks ]
    Compliance to treatment defined as proportion taking >80% study medication (good), 60-80% (satisfactory) and <60% (poor)
  • Patient quality of life [ Time Frame: up to 17 weeks ]
    Patients will report a Quality Of Life (QOL) review


Original Secondary Outcome: Same as current

Information By: Entera Bio Ltd.

Dates:
Date Received: April 22, 2014
Date Started: July 2014
Date Completion:
Last Updated: October 6, 2015
Last Verified: October 2015