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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152228
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Entera Bio Ltd.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152228


Locations
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Israel
Lin Medical Center
Haifa, Israel, 35152
Sponsors and Collaborators
Entera Bio Ltd.
Investigators
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Principal Investigator: Sophia Ish Shalom, MD Rambam Health Care Campus
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Responsible Party: Entera Bio Ltd.
ClinicalTrials.gov Identifier: NCT02152228    
Other Study ID Numbers: ENT-03-2014
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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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