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A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
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.
Details
| Lead sponsor | Entera Bio Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2014-07 |
| Completion | 2015-07 |
Conditions
- Hypoparathyroidism
Interventions
- EnteraBio's Oral Parathyroid Hormone (1-34)
Primary outcomes
- Number of participants with adverse events — 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 — up to 17 weeks
- Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events — up to 17 weeks
- Plasma calcium levels — at baseline and 60 minutes post-dose
- Peak Plasma Concentration (Cmax)of treatment — at baseline and time-points post-dose
To study the pharmacokinetic profile of PTH absorption
Countries
Israel