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

• ClinicalTrials.gov Identifier: NCT02152228
• Recruitment Status: Completed
• First Posted: June 2, 2014
• Last Update Posted: October 7, 2015
• Sponsor: Entera Bio Ltd.
• Information provided by (Responsible Party): Entera Bio Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypoparathyroidism	Drug: EnteraBio's Oral Parathyroid Hormone (1-34)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
• Study Start Date: July 2014
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

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 Name: Teriparatide

Outcome Measures

Primary Outcome Measures :

1. 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
2. Reduction in use of exogenous calcium supplement and/or alpha D3 supplement [ Time Frame: up to 17 weeks ]
3. Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events [ Time Frame: up to 17 weeks ]
4. Plasma calcium levels [ Time Frame: at baseline and 60 minutes post-dose ]
5. Peak Plasma Concentration (Cmax)of treatment [ Time Frame: at baseline and time-points post-dose ]
   To study the pharmacokinetic profile of PTH absorption

Secondary Outcome Measures :

1. The volunteers' compliance to treatment [ Time Frame: up to 17 weeks ]
   Compliance to treatment defined as proportion taking >80% study medication (good), 60-80% (satisfactory) and <60% (poor)
2. Patient quality of life [ Time Frame: up to 17 weeks ]
   Patients will report a Quality Of Life (QOL) review

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Israel

Lin Medical Center

Haifa, Israel, 35152

Sponsors and Collaborators

Entera Bio Ltd.

Investigators

• Principal Investigator: Sophia Ish Shalom, MD; Rambam Health Care Campus

More Information

• Responsible Party: Entera Bio Ltd.
• ClinicalTrials.gov Identifier: NCT02152228
• Other Study ID Numbers: ENT-03-2014
• First Posted: June 2, 2014
• Last Update Posted: October 7, 2015
• Last Verified: October 2015

Additional relevant MeSH terms:

Hypoparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Teriparatide; Hormones; Parathyroid Hormone; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Bone Density Conservation Agents