JPRN-jRCT2051210058进行中（未招募）3 期
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 个研究点目标入组 12 人开始时间: 2021年7月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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)
- •6. Body mass index (BMI) 17- 40 kg/m^2 at Screening
- •7. If <=25 years of age, radiological evidence of epiphyseal closure based on X-ray of nondominant wrist and hand
- •8. 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
- •9. If treated with thyroid hormone replacement therapy, the dose must have been stable for at least 5 weeks prior to Screening
- •10. Estimated glomerular filtration rate (eGFR) >=30 mL/min/1.73 m^2 during Screening
- •11. Able to perform daily subcutaneous self-injections of TransCon PTH (or have a designee to perform injections) via a pre-filled injection pen
- •12. Able and willing to provide written and signed Informed Consent Form in accordance with Good Clinical Practice .
排除标准
- •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
- •11. Pregnant or lactating women
- •12. 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
- •13. Diagnosed drug or alcohol dependence within 3 years prior to Screening
- •14. 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 autoimmune regulator (AIRE) gene mutations with malabsorption
- •15. Chronic or 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 blood pressure (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 isolat
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