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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Oral administration
Lin Medical Center
Haifa, Israel
Number of participants with adverse events
safety will be measured by monitoring and recording adverse events related to hyper- and hypocalcemia
Time frame: up to 17 weeks
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
To study the pharmacokinetic profile of PTH absorption
Time frame: at baseline and time-points post-dose
The volunteers' compliance to treatment
Compliance to treatment defined as proportion taking \>80% study medication (good), 60-80% (satisfactory) and \<60% (poor)
Time frame: up to 17 weeks
Patient quality of life
Patients will report a Quality Of Life (QOL) review
Time frame: up to 17 weeks
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