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.

Study Overview

• Status: Completed
• Conditions: Hypoparathyroidism
• Intervention / Treatment: Drug: EnteraBio's Oral Parathyroid Hormone (1-34)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 35152
    • Lin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Pregnancy or suspected pregnancy. Female subjects must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control (reliable use of oral contraceptive, non-hormonal intrauterine device with condom, or diaphragm with condom, or condom with spermicide) from the screening visit through the study termination visit or declare that they are abstaining from sexual intercourse from the screening visit through the study termination visit or are surgically sterile (have undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Parathyroid Hormone (1-34); Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34)	Drug: EnteraBio's Oral Parathyroid Hormone (1-34); Oral administration; Other Names: Teriparatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Patients will report a Quality Of Life (QOL) review	up to 17 weeks

Collaborators and Investigators

• Sponsor: Entera Bio Ltd.
• Investigators: Principal Investigator: Sophia Ish Shalom, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hypoparathyroidism; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Hormones; Teriparatide; Parathyroid Hormone
• Other Study ID Numbers: ENT-03-2014