PaTHway CHINA TRIAL: A Trial to Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism

  • STATUS
    Recruiting
  • End date
    Dec 4, 2025
  • participants needed
    76
  • sponsor
    Visen Pharmaceuticals (Shanghai) Co., Ltd.
Updated on 4 June 2022
calcium
replacement therapy
calcitriol
serum calcium
vitamin
active vitamin d
thyroid-stimulating hormone
hypocalcemia
magnesium level
tsh level
serum parathyroid hormone

Summary

This study is limited to conduct in China only. The primary objective is to assess the treatment effect of daily TransCon PTH on serum calcium (sCa) levels within the normal range and stopping from therapeutic doses of active vitamin D (calcitriol) or active vitamin D analogue (alfacalcidol) and calcium at 26 weeks of treatment. All subjects will start with 18 mcg of study drug and will be individually and progressively titrated to an optimal dose over a 26-week double blind period, followed by an open label extension period up to 156 weeks. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs.

Description

Not Provided

Details
Condition Hypoparathyroidism, Parathyroid Hormone Deficiency, Endocrine System Diseases, Parathyroid Diseases
Treatment Placebo, TransCon PTH
Clinical Study IdentifierNCT05387070
SponsorVisen Pharmaceuticals (Shanghai) Co., Ltd.
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females, ≥18 years of age
Subjects with postsurgical chronic HP, or auto-immune, genetic, or idiopathic HP for at least 26 weeks. Diagnosis of HP is established based on historic hypocalcemia in the setting of inappropriately low (below the ULN of local laboratory) serum PTH levels
Requirement for doses of SoC (e.g., calcitriol, alfacalcidol, calcium supplements) at or above a minimum threshold
• requirement for a dose of calcitriol ≥0.5 μg/day, or alfacalcidol ≥1.0
μg/day and (elemental) calcium ≥800 mg/day (e.g., calcium citrate, calcium
carbonate etc.) for at least 12 weeks prior to Screening. In addition, the
dose of calcitriol, or alfacalcidol, and calcium should be stable for at least
weeks prior to Screening
Optimization of supplements prior to randomization to achieve the target serum levels
of
(OH) vitamin D levels of 10-100 ng/mL (25-250 nmol/L) and
Magnesium level in the normal range, or just below the normal range i.e.: ≥1.3 mg/dL (0.53 mmol/L) and
Albumin-adjusted sCa level in the normal range, or just below the normal range, i.e.: 7.8-10.6 mg/dL (or 1.95-2.64 mmol/L)
The subject demonstrates a 24-hour uCa excretion of ≥125 mg/24h (on a sample collected
within 52 weeks prior to Screening or during the Screening Period)
BMI 17- 40 kg/m2 at Screening
If ≤25 years of age, radiological evidence of epiphyseal closure based on X-ray of non-dominant wrist and hand
Thyroid-stimulating hormone (TSH) within normal laboratory limits within the 6 weeks prior to Visit 1; if on suppressive therapy for a history of thyroid cancer, TSH level must be ≥0.2 mIU/L
If treated with thyroid hormone replacement therapy, the dose must have been stable for at least 5 weeks prior to Screening
eGFR ≥30 mL/min/1.73 m2 during Screening
Able to perform daily SC self-injections of study drug (or have a designee to perform injections) via a pre-filled injection pen
Able and willing to provide written and signed ICF in accordance with GCP

Exclusion Criteria

Impaired responsiveness to PTH (pseudohypoparathyroidism) which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia
Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HP, such as active hyperthyroidism; Paget disease of bone; severe hypomagnesemia; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1C >9%, documented HbA1C result drawn within 12 weeks prior to Screening is acceptable); severe and chronic liver, or renal disease; Cushing syndrome; multiple myeloma; active pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy (other than low-risk well differentiated thyroid cancer or non-melanoma skin cancer); active hyperparathyroidism; parathyroid carcinoma within 5 years prior to Screening; acromegaly;or multiple endocrine neoplasia
High risk thyroid cancer within 2 years, requiring suppression of TSH <0.2 mIU/L
Long term use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin >30 µg/day, or systemic corticosteroids (other than as replacement therapy)
Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1
Use of PTH-like drugs (whether commercially available or through participation in an investigational trial), including PTH (1-84), PTH (1-34), or other N-terminal fragments or analogs of PTH or PTH-related protein, within 4 weeks prior to Screening
Use of other drugs known to influence calcium and bone metabolism, such as calcitonin, fluoride tablets (>0.5 mg/day), strontium, or cinacalcet hydrochloride, within 12 weeks prior to Screening
Use of osteoporosis therapies known to influence calcium and bone metabolism, i.e., bisphosphonate (oral or intravenous [IV]), denosumab, raloxifene, or romosozumab therapies within 2 years prior to Screening
Non-hypocalcemic seizure disorder with a history of a seizure within 26 weeks prior to Screening
Increased risk for osteosarcoma, such as those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of substantial external beam or implant radiation therapy involving the skeleton
Pregnant or lactating women
Male who has a female partner who intends to become pregnant or is of childbearing potential and is unwilling to use adequate contraceptive methods during the trial
Diagnosed drug or alcohol dependence within 3 years prior to Screening
Disease processes that adversely affect gastrointestinal absorption, including but not limited to short bowel syndrome, significant small bowel resection, gastric bypass, tropical sprue, active celiac disease, active ulcerative colitis, active Crohn's disease, gastroparesis and AIRE gene mutations with malabsorption
Severe cardiac disease within 26 weeks prior to Screening including but not limited to congestive heart failure, myocardial infarction, severe or uncontrolled arrhythmias, bradycardia (resting heart rate <48 beats/minute, unless chronic and asymptomatic), symptomatic hypotension or systolic BP <80 mm Hg or diastolic <40 mm Hg or poorly controlled hypertension (systolic BP >165 mm Hg or diastolic >95 mm Hg). In the absence of a prior history of hypertension, an isolated BP >165/95 mm Hg in the setting of white coat hypertension/anxiety may not be exclusionary and a measurement can be repeated prior to randomization
Cerebrovascular accident within 5 years prior to Screening
Within 26 weeks prior to Screening: acute colic due to nephrolithiasis, or acute gout. Subjects with asymptomatic renal stones are permitted
Participation in any other interventional trial in which receipt of investigational drug or device occurred within 8 weeks (or within 5.5 times the half-life of the investigational drug) (whichever comes first) prior to Screening
Any disease or condition that, in the opinion of the investigator, may require treatment or make the subject unlikely to fully complete the trial, or any condition that presents undue risk from the investigational product or procedures, including treated malignancies that are likely to recur within the approximate 3.5-year duration of the trial
Known allergy or sensitivity to PTH or any of the excipients [metacresol, mannitol, succinic acid, NaOH/(HCl)]
Likely to be non-compliant with respect to trial conduct
Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule
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