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

NCT02152228 | Completed Phase 2

• 1 other identifier: ENT-03-2014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoparathyroidism

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• The volunteers' compliance to treatment

  up to 17 weeks

• Patient quality of life

  up to 17 weeks

Study Arms (1)

Oral Parathyroid Hormone (1-34)

EXPERIMENTAL

Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34)

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

Interventions

EnteraBio's Oral Parathyroid Hormone (1-34) DRUG

Oral administration

Also known as: Teriparatide

Oral Parathyroid Hormone (1-34)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of primary hypoparathyroidism for more than 1 year.
• Currently taking \>1.0 grams of Calcium/day with a correlate alpha D3 dose.
• (OH)D levels ≥ 20 ng/ml.
• Signed informed consent.
• BMI 18 - 30 kg/m2, inclusive.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Entera Bio Ltd.: lead

Study Sites (1)

Lin Medical Center

Haifa, 35152, Israel

Location

MeSH Terms

Conditions

Hypoparathyroidism

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Sophia Ish Shalom, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

IL (1)