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

Hypoparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152228
• Other study ID #: ENT-03-2014
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2014
• Last updated: October 6, 2015
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Entera Bio Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyIsrael: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoparathyroidism

Intervention

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

Locations

Country	Name	City	State
Israel	Lin Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Entera Bio Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Reduction in use of exogenous calcium supplement and/or alpha D3 supplement		up to 17 weeks	No
Primary	Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events		up to 17 weeks	No
Primary	Plasma calcium levels		at baseline and 60 minutes post-dose	No
Primary	Peak Plasma Concentration (Cmax)of treatment	To study the pharmacokinetic profile of PTH absorption	at baseline and time-points post-dose	No
Secondary	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	No
Secondary	Patient quality of life	Patients will report a Quality Of Life (QOL) review	up to 17 weeks	No