A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
Overview
- Phase
- Phase 2
- Intervention
- EnteraBio's Oral Parathyroid Hormone (1-34)
- Conditions
- Hypoparathyroidism
- Sponsor
- Entera Bio Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of primary hypoparathyroidism for more than 1 year.
- •Currently taking \>1.0 grams of Calcium/day with a correlate alpha D3 dose.
- •25(OH)D levels ≥ 20 ng/ml.
- •Signed informed consent.
- •BMI 18 - 30 kg/m2, inclusive.
- •Full blood count should be within the reference range as per WHO criteria. Minor abnormalities will be assessed by the Principle Investigator and after discussion with sponsor patients may still be entered if these are felt to be of "no clinical importance". Abnormalities due to hypoparathyroidism related are acceptable and will not constitute exclusion.
- •Patients with significant liver function impairment (liver enzymes above x3 the upper limit of normal range as per WHO criteria) will be excluded.
- •Subjects able to adhere to the visit schedule and protocol requirements.
Exclusion Criteria
- •Haemoglobin \<12 g/dL (females)/ \<13gm/dL (males) \[lower limit of reference range 12-15 \& 13-17\]
- •Impaired renal function
- •impaired liver function; ALT \>38 international units per liter (IU/L), or ALP\>125 IU/L
- •Significant drug or alcohol abuse as assessed by the Principal Investigator
- •Allergy to soy bean products
- •Presence of kidney or urinary tract stones
- •Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- •Treatment with any investigational product within the last 30 days, enrollment or intention to enroll in any active study involving the use of investigational devices or drugs.
- •Presence of any other condition or circumstance that, in the judgment of the Investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- •Active infections
Arms & Interventions
Oral Parathyroid Hormone (1-34)
Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34)
Intervention: EnteraBio's Oral Parathyroid Hormone (1-34)
Outcomes
Primary Outcomes
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
Peak Plasma Concentration (Cmax)of treatment
Time Frame: at baseline and time-points post-dose
To study the pharmacokinetic profile of PTH absorption
Plasma calcium levels
Time Frame: at baseline and 60 minutes post-dose
Secondary Outcomes
- Patient quality of life(up to 17 weeks)
- The volunteers' compliance to treatment(up to 17 weeks)