JPRN-jRCT2051210058
Active, not recruiting
Phase 3
A Phase 3, Multicenter, Single Arm, Open-Label Trial, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Japanese Adult Subjects with Hypoparathyroidism - PaTHway Japan Trial
Sibley Christopher0 sites12 target enrollmentJuly 30, 2021
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sibley Christopher
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males and females, at least 18 years\-old
- •2\. Subjects with postsurgical chronic hypoparathyroidism(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 serum PTH levels
- •3\. Requirement for a dose of calcitriol \>\=1\.0 microgram/day, or alfacalcidol \>\=2\.0 microgram/day for at least 12 weeks prior to Screening. In addition, the dose of calcitriol or alfacalcidol should be stable for at least 5 weeks prior to Screening.
- •4\. Optimization of supplements prior to Visit 1 to achieve the target serum levels of:
- •\- 25(OH) vitamin D levels of 20\-80 ng/mL (49\-200 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 or ionized serum Ca(sCa) level in the normal range, or just below the normal range
- •\- Albumin\-adjusted sCa 7\.8\-10\.6 mg/dL (or 1\.95\-2\.64 mmol/L)
- •\- Ionized sCa 4\.40\-5\.29 mg/dL (or 1\.10\-1\.32 mmol/L)
- •5\. The subject demonstrates a 24\-hour urine Ca(uCa) excretion of \>\=125 mg/24h (on a sample collected within 52 weeks prior to Screening or during the Screening Period)
Exclusion Criteria
- •1\. Impaired responsiveness to PTH(pseudohypoparathyroidism) which is characterized as PTH\-resistance, with elevated PTH levels in the setting of hypocalcemia
- •2\. 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 types 1 and 2
- •3\. High risk thyroid cancer within 2 years, requiring suppression of TSH \<0\.2 mIU/L
- •4\. Use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin \>30 microgram/day, or systemic corticosteroids (other than as replacement therapy)
- •5\. Use of thiazide diuretic within 4 weeks prior to the 24\-hour urine collection scheduled to occur within 1 week prior to Visit 1
- •6\. 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
- •7\. 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
- •8\. 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
- •9\. Non\-hypocalcemic seizure disorder with a history of a seizure within 26 weeks prior to Screening
- •10\. 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
Outcomes
Primary Outcomes
Not specified
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