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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Parathyroid Hormone (1-34) | Experimental | Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnteraBio's Oral Parathyroid Hormone (1-34) | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | safety will be measured by monitoring and recording adverse events related to hyper- and hypocalcemia | up to 17 weeks |
| 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 | To study the pharmacokinetic profile of PTH absorption | at baseline and time-points post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| The volunteers' compliance to treatment | Compliance to treatment defined as proportion taking >80% study medication (good), 60-80% (satisfactory) and <60% (poor) | up to 17 weeks |
| Patient quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophia Ish Shalom, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lin Medical Center | Haifa | 35152 | Israel |
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| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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Patients will report a Quality Of Life (QOL) review
| up to 17 weeks |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |