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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.

Tracking Information
First Submitted Date  ICMJE April 22, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date October 7, 2015
Study Start Date  ICMJE July 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
  • 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
  • Reduction in use of exogenous calcium supplement and/or alpha D3 supplement [ Time Frame: up to 17 weeks ]
  • Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events [ Time Frame: up to 17 weeks ]
  • Plasma calcium levels [ Time Frame: at baseline and 60 minutes post-dose ]
  • Peak Plasma Concentration (Cmax)of treatment [ Time Frame: at baseline and time-points post-dose ]
    To study the pharmacokinetic profile of PTH absorption
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • 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
  • Reduction in use of exogenous calcium supplement and/or alpha D3 supplement [ Time Frame: up to 17 weeks ]
  • Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events [ Time Frame: up to 17 weeks ]
  • Plasma calcium levels [ Time Frame: at baseline and 60 minutes post-dose ]
  • Peak Plasma Concentration (Cmax)of treatment [ Time Frame: at baseline and time-points 10, 15, 20, 30, 45, 60, 90, and 180 post-dose ]
    To study the pharmacokinetic profile of PTH absorption
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • 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)
  • Patient quality of life [ Time Frame: up to 17 weeks ]
    Patients will report a Quality Of Life (QOL) review
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
Official Title  ICMJE A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypoparathyroidism
Intervention  ICMJE Drug: EnteraBio's Oral Parathyroid Hormone (1-34)
Oral administration
Other Name: Teriparatide
Study Arms  ICMJE Experimental: Oral Parathyroid Hormone (1-34)
Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34)
Intervention: Drug: EnteraBio's Oral Parathyroid Hormone (1-34)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
15
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152228
Other Study ID Numbers  ICMJE ENT-03-2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Entera Bio Ltd.
Study Sponsor  ICMJE Entera Bio Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sophia Ish Shalom, MD Rambam Health Care Campus
PRS Account Entera Bio Ltd.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP