A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2015
• Main ID: NCT02152228
• Date of registration: 22/04/2014
• Prospective Registration: Yes
• Primary sponsor: Entera Bio Ltd.
• Public title: A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
• Scientific title: A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
• Date of first enrolment: July 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02152228
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Israel

Contacts

• Name: Sophia Ish Shalom, MD
• Affiliation: Rambam Health Care Campus

Key inclusion & exclusion 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

- 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypoparathyroidism

Intervention(s)

Drug: EnteraBio's Oral Parathyroid Hormone (1-34)

Primary Outcome(s)

Plasma calcium levels [Time Frame: at baseline and 60 minutes post-dose]

Reduction in use of exogenous calcium supplement and/or alpha D3 supplement [Time Frame: up to 17 weeks]

Peak Plasma Concentration (Cmax)of treatment [Time Frame: at baseline and time-points post-dose]

Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events [Time Frame: up to 17 weeks]

Number of participants with adverse events [Time Frame: up to 17 weeks]

Secondary Outcome(s)

The volunteers' compliance to treatment [Time Frame: up to 17 weeks]

Patient quality of life [Time Frame: up to 17 weeks]

Secondary ID(s)

ENT-03-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors