EUCTR2020-003380-26-DE进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males and females, =18 years of age
- •2. Subjects with postsurgical chronic HP, or auto-immune, genetic, or idiopathic HP for at least 26 weeks. Diagnosis of HP is established based on history of hypocalcemia in the setting of inappropriately low serum PTH levels (Hypocalcemia is defined as a value below the reference
- •range for normal at the performing laboratory. Inappropriately low serum PTH levels are defined as at or below the median value of the
- •reference range for normal at the performing laboratory while the concomitant serum calcium is low. If specific lab results at the time of original diagnosis are not available, as historical diagnosis affirming
- •these two components is adequate for inclusion).
- •3. Requirement for doses of SOC eg, calcitriol, alfacalcidol, calcium supplements) at or above a minimum threshold:
- •For countries other than Japan: requirement for a dose of calcitriol =0.5 µg day, or alfacalcidol =1.0 µg day and (elemental) calcium =800 mg day (eg, calcium citrate, calcium carbonate etc.) for at least 12 weeks prior to Screening*. In addition, the dose of calcitriol, or alfacalcidol, or calcium should be stable** for at least 5 weeks prior to Screening.
- •* Excluding individuals receiving PTH-like drugs within 12 weeks of the screening visit, who need only demonstrate a stable requirement for elemental calcium and active vitamin D above minimum thresholds for 5 weeks prior to the screening visit.
- •** Does not preclude occasional (=2/week) PRN doses of calcium and/or active vitamin D for symptomatic hypocalcemia
- •4. Optimization of supplements prior to randomization 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 sCa level in the normal range, or *just below the normal range, i.e.:
- •- 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)
- •*Just below the normal range implies the numerical range of 7.8-8.2 mg/dL (or 1.95-2.06 mmol/L) for albumin-adjusted sCa and the numerical range of 4.40-4.636 mg/dL (or 1.10-1.159 mmol/L) for ionized sCa.
- •5. 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)
- •Note: Although 24-hour urine samples prior to Screening may be done on or off thiazide therapy, thiazide therapy is prohibited during the trial; and the 24-hour urine collection scheduled prior to Visit 1 must be done while off thiazides for at least 4 weeks prior to collection
- •6. BMI 17- 40 kg/m2 at Screening
- •7. If =25 years of age, radiological evidence of epiphyseal closure based on X-ray of non-dominant 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. eGFR =30 mL/min/1.73 m2 during Screening
- •11. Able to perform daily SC self-injections of study drug (or have a designee to perform injections) via a pre-filled injection pen
- •12. Able and willing to provide written and signed ICF in accordance with GCP.
- •13. For France only: The subject is obligated to be affiliated with, or beneficiary of a social s
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; bone Paget disease; 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 cell 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 µg/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; Note: Male subjects must use a condom, or his female partner of childbearing potential must use an effective form of contraception (as per CTFG definition), from the beginning of screening to the last trial visit
- •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 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 BP <80 mm
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