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Chronic HypoparathyroidismPhase 3NCT03878953

A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism

A Phase 3 study testing rhPTH(1-84) in people with Chronic Hypoparathyroidism, run by Shire at 10 sites in Japan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This clinical study aims to evaluate the safety and efficacy of repeated dosing of recombinant human parathyroid hormone (rhPTH[1-84]) in Japanese participants with chronic hypoparathyroidism for a 26-week period. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Chronic Hypoparathyroidism
What is being tested?
rhPTH(1-84)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
10 sitesJapan
Study dates
31 Aug 2022to 31 May 2023
Phase
Phase 3
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 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant has signed and dated the informed consent form.
  • The participant is an adult male or female 20 to 85 years of age inclusive.
  • The participant is living in Japan and is Japanese; in this case, Japanese is defined as having been born in Japan, with Japanese parents, and Japanese maternal and paternal grandparents.
  • The participant has a diagnosis of chronic hypoparathyroidism with an onset of 18 months or more prior to screening. The diagnosis is based on historical biochemical evidence of hypocalcemia in the setting of a concomitant inappropriately low serum intact parathyroid hormone (PTH). If such evidence is not available the diagnosis of chronic hypoparathyroidism must be confirmed by the Shire medical monitor based on other compelling medical history.
  • The participant has been treated with active vitamin D therapy with alfacalcidol greater than or equal to (>=) 1 microgram (mcg) per day (or an equivalent dose of calcitriol of >=0.5 mcg per day or falecalcitriol >=0.3 mcg per day) prior to baseline.
  • The participant has indicated a willingness and ability to perform daily subcutaneous (SC) self-injections of study medication (or will have a designee, ie, a family member or caregiver, to perform injections).
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  • Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol.
  • The participants who are less than (<) 25 years old demonstrate radiological evidence of epiphyseal closure at screening based on bone age X-ray (single posteroanterior X-ray of the left wrist and hand).
  • The participant meets 1 of the following criteria:
  • If not receiving thyroid hormone replacement therapy, the participant has a serum thyroid stimulating hormone (TSH) level within normal laboratory limits at screening.
  • If receiving thyroid hormone replacement therapy, the dose must have been stable for at least 3 months prior to screening and serum TSH level within the reference range for the laboratory.
  • The participant has a 25-hydroxyvitamin D level >=50 nanomoles per litre (nmol/L) (20 nanogram per milliliter [ng/mL]) and < upper limit of normal (ULN) of the laboratory reference range.
  • The participant has a serum creatinine laboratory value of <132.6 micromoles per liter (mcmoles/L) (1.5 milligram per deciliter [mg/dL]).
  • The participant has a serum magnesium level within the laboratory reference range at baseline.
  • The participant is not adequately controlled with standard therapy within 6 months of screening based upon the opinion of the investigator and approval by the sponsor's medical monitor. For example:
  • Hypocalcemia (albumin-corrected serum calcium <8.0 mg/dL) or
  • Hypercalciuria (urine calcium [mg/dL]/creatinine [mg/dL] ratio >0.4 or 24 hour urine calcium excretion >7.5 millimoles (mmol) [300 milligram {mg}]/24 hours in men and >6.25 millimoles (mmol) [250 mg]/24 hours in women) or,
  • Symptoms of hypoparathyroidism.

Who cannot join

  • The participant and/or legally authorized representative(s) is unable to understand the nature, scope, and possible consequences of the study.
  • The participant is unable to comply with the protocol, eg, uncooperative with protocol schedule, refusal to agree to all of the study procedures, inability to return for evaluations, or is otherwise unlikely to complete the study, as determined by the investigator or the medical monitor.
  • The participant has any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism, Paget's disease, type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8%), severe and chronic cardiac, liver or renal disease, Cushing's syndrome, neuromuscular disease, rheumatoid arthritis, myeloma, pancreatitis, malnutrition, rickets, recent prolonged immobility, active malignancy, primary or secondary hyperparathyroidism, a history of parathyroid carcinoma, hypopituitarism, acromegaly, or multiple endocrine neoplasia types I and II.
  • The participant has a known history of hypoparathyroidism resulting from an activating mutation in the CaSR gene or impaired responsiveness to PTH (pseudohypoparathyroidism).
  • The participant is taking prohibited medications (listed below) or other drugs known to influence calcium and bone metabolism during their respective prohibited periods.
  • The following prohibited medications should not be taken within the specified number of days prior to the first dose of rhPTH(1-84): i) 30 days: loop diuretics, thiazide diuretics, phosphate binders (other than calcium carbonate), calcitonin, cinacalcet hydrochloride.
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  • 90 days: lithium. iii) 127 days: denosumab. iv) 180 days: digoxin, raloxifene hydrochloride, estrogens and progestins for hormone replacement therapy, methotrexate, systemic corticosteroids, oral bisphosphonates*.
  • 365 days: sodium fluoride, intravenous bisphosphonates*. Note: *The length of the washout period is dependent on the route of administration of bisphosphonate that is being used by the participant.
  • The participant has previous treatment or participation in an investigational trial with PTH-like drugs, including PTH(1-84), PTH(1-34) or other N terminal fragments or analogs of PTH or PTH-related protein within 6 months prior to screening.
  • The participant has nonhypocalcemic seizure disorder/epilepsy with a history of a seizure within the previous 6 months prior to screening; note that participant with a history of seizures due to hypocalcemia are allowed.
  • The participant has any disease or condition, in the opinion of the investigator, which has a high probability of precluding the participant from completing the study or that the participant cannot or will not appropriately comply with study requirements.
  • The participant has participated in any other investigational trial in which receipt of investigational drug or device occurred within 6 months prior to screening for this study.
  • The participant is pregnant or breastfeeding.
  • The participant has a history of diagnosed drug or alcohol dependence within the previous 3 years.
  • The participant has a history of gout.
  • The participant has disease processes that may adversely affect gastrointestinal absorption, including but not limited to short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohn's disease.
  • The participant has chronic or severe cardiac disease including, but not limited to, heart failure (according to the New York Heart Association classification Class II to Class IV) (Dolgin and NYHA 1994), arrhythmias, bradycardia (resting pulse rate <50 beats/minute), or hypotension (systolic and diastolic blood pressures <100 and 60 millimeters of mercury (mmHg), respectively).
  • The participant has a history of cerebrovascular accident.
  • The participant has a known or suspected intolerance or hypersensitivity to the investigational product, PTH derivatives, or any of the stated ingredients.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Japan10 sites

  • University of Tokyo Hospital

    Bunkyō City, Tokyo-To, 113-8655

  • Shimane University Hospital

    Izumo-shi, Shimane, 693-8501

  • University of Occupational and Environmental Health Japan

    Kitakyushu-shi, Fukuoka, 807-8556

  • The Cancer Institute Hospital of JFCR

    Kōtoku, Tokyo-To, 135-8550

  • Toranomon Hospital

    Minatoku, Tokyo-To, 105-8470

  • Osaka City University Hospital

    Osaka, Osaka, 545-8586

  • Keio University Hospital

    Shinjuku-ku, Tokyo-To, 160-8582

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo-To, 162-8666

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken, 470-1192

Other trials in Japan

About this study

Official title: A Phase 3, Open-label Clinical Study of rhPTH(1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism

This clinical study aims to evaluate the safety and efficacy of repeated dosing of recombinant human parathyroid hormone (rhPTH[1-84]) in Japanese participants with chronic hypoparathyroidism for a 26-week period.

Being tested
rhPTH(1-84)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhPTH(1-84)Drug

    Participants will receive a SC injection of initial dose of 50 mcg of rhPTH(1-84) once daily (QD) in the thigh (alternate thigh every day). If albumin-corrected serum calcium (ACSC; [mg/dL] = serum calcium [mg/dL] +0.8*[4-serum albumin (g/dL)]) is >2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg will be considered. At 4 week intervals the rhPTH(1-84) dose may be increased in 25 mcg increments to a maximal dose of 100 mcg SC QD. At any time during the study as needed for safety reasons, rhPTH(1-84) doses may be decreased in 25 mcg decrements to a minimum of 25 mcg QD. If the ACSC is >2.97 mmol/L (>11.9 mg/dL), then the investigational product should be stopped until the calcium level is corrected.

Study groups in NCT03878953
Study groupRoleWhat they receive
rhPTH(1-84)ExperimentalParticipants will receive a SC injection of initial dose of 50 mcg of rhPTH(1-84) once daily (QD) in the thigh (alternate thigh every day). If albumin-corrected serum calcium (ACSC; [mg/dL] = serum calcium [mg/dL] +0.8*[4-serum albumin (g/dL)]) is >2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg will be considered. At 4 week intervals the rhPTH(1-84) dose may be increased in 25 mcg increments to a maximal dose of 100 mcg SC QD. At any time during the study as needed for safety reasons, rhPTH(1-84) doses may be decreased in 25 mcg decrements to a minimum of 25 mcg QD. If the ACSC is >2.97 mmol/L (>11.9 mg/dL), then the investigational product should be stopped until the calcium level is corrected.
Receives: Drug: rhPTH(1-84)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Responders at Week 26

    Number of participants who achieved an albumin-corrected total serum calcium concentration that is maintained or normalized compared to baseline and does not exceed the upper limit of the reference range for the laboratory, at least a 50% reduction from baseline amounts of active vitamin D therapy and at least a 50% reduction from the baseline oral calcium supplement dose (this criterion will be considered met if the participant's baseline calcium dose is <1000 mg and it does not increase during the study will be reported.

    Measured: Week 26

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this study treatment. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the investigational product or medicinal product.

    Measured: From start of study treatment up to 30 weeks

Secondary outcomes (2)

  1. Change From Baseline in Serum Phosphate Level

    Change from baseline in serum phosphate level will be reported.

    Measured: Baseline, Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 26 and 30

  2. Change From Baseline in Urine Calcium Level

    Change from baseline in urine calcium level will be reported.

    Measured: Baseline, Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start31 Aug 2022 (estimated)
  3. Primary completion31 May 2023 (estimated)
  4. Study completion31 May 2023 (estimated)

Why it stopped: Business decision

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03878953
Sponsor's protocol ID
SHP634-301
Other IDs
JapicCTI-194828
Status last verified
Oct 2022
First submitted
15 Mar 2019
Last updated
10 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhPTH(1-84) in people with Chronic Hypoparathyroidism, run by Shire at 10 sites in Japan.

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 18 inclusion and 19 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: withdrawn, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was withdrawn before enrolling participants, so there are no results.

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 Responders at Week 26 (time frame: Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03878953.

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 10 Oct 2022.

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