HypoparathyroidismPhase 2NCT02152228
A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
A Phase 2 study testing EnteraBio's Oral Parathyroid Hormone (1-34) in people with Hypoparathyroidism, run by Entera Bio Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- EnteraBio's Oral Parathyroid Hormone (1-34)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- EnteraBio's Oral Parathyroid Hormone (1-34)
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnteraBio's Oral Parathyroid Hormone (1-34)Drug
Also called Teriparatide
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Oral Parathyroid Hormone (1-34) | Experimental | Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34) Receives: Drug: EnteraBio's Oral Parathyroid Hormone (1-34) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
safety will be measured by monitoring and recording adverse events related to hyper- and hypocalcemia
Measured: up to 17 weeks
Reduction in use of exogenous calcium supplement and/or alpha D3 supplement
Measured: up to 17 weeks
Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events
Measured: up to 17 weeks
Plasma calcium levels
Measured: at baseline and 60 minutes post-dose
Peak Plasma Concentration (Cmax)of treatment
To study the pharmacokinetic profile of PTH absorption
Measured: at baseline and time-points post-dose
Secondary outcomes (2)
The volunteers' compliance to treatment
Compliance to treatment defined as proportion taking >80% study medication (good), 60-80% (satisfactory) and <60% (poor)
Measured: up to 17 weeks
Patient quality of life
Patients will report a Quality Of Life (QOL) review
Measured: up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entera Bio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sophia Ish Shalom, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152228
- Sponsor's protocol ID
- ENT-03-2014
- Status last verified
- Oct 2015
- First submitted
- 22 Apr 2014
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT02152228
- Acronym / sponsor ID
- ENT-03-2014
- Conditions
- Hypoparathyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Entera Bio Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Parathyroid Hormone (1-34) | Experimental | Drug: EnteraBio's Oral Parathyroid Hormone (1-34)Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnteraBio's Oral Parathyroid Hormone (1-34)Also: TeriparatideOral administration | Drug | Oral Parathyroid Hormone (1-34) |
Primary outcome
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
2 secondary outcomes
The volunteers' compliance to treatment
Time frame: up to 17 weeks
Patient quality of life
Time frame: up to 17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Ish Shalom, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EnteraBio's Oral Parathyroid Hormone (1-34) in people with Hypoparathyroidism, run by Entera Bio Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: up to 17 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.