EUCTR2017-000284-32-ES进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
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
- 性别
- All
入选标准
- •1. Has an understanding, ability, and willingness to fully comply with study procedures and
- •restrictions.
- •2. Is able to voluntarily provide a signed and dated informed consent form before any study-related procedures are performed.
- •3. Is an adult male or female 18 to 85 years of age, inclusive.
- •4. In subjects 25 years of age or younger, has radiological evidence of epiphyseal closure based on X-ray of left wrist and left hand before randomization.
- •5. Has a history of hypoparathyroidism with onset 12 months or more before screening. The diagnosis of hypoparathyroidism is established based on hypocalcemia in the setting of inappropriately low serum PTH levels.
- •6. During the Week -3 screening visit, the subject reports by history at least 2 of the following symptoms related to hypoparathyroidism occurring within the 2 weeks before Week -3 visit: muscle cramps, muscle spasms or twitching, tingling, numbness, heaviness in arms or legs, physical fatigue, or slowed or confused thinking (brain fog).
- •7. Based on the results of the Hypoparathyroidism Symptom Diary (HPT-SD) administered
- •during the first week of the screening period (from Week -3 to Week -2 visits), the
- •subject reports at least 2 of the following symptoms that average at least moderate in
- •intensity: muscle cramps, muscle spasms or twitching, tingling, numbness, heaviness in
- •arms or legs, physical fatigue, or slowed or confused thinking (brain fog). Additionally,
- •the sum score of the HPT-SD symptom subscale (items 1-7) measured during the first
- •week of the screening period must be =6 (see Appendix 3). At least 4 responses must be
- •entered for each symptom.
- •8. Must be treated with active vitamin D (calcitriol or alfacalcidol) alone or in conjunction
- •with calcium supplements.
- •?If treated with active vitamin D alone, the subject must be taking =0.5 µg/day of calcitriol or =1.0 µg/day of alfacalcidol. If treated with <0.5 µg/day of calcitriol or <1.0 µg/day of alfacalcidol, the subject must have a history of inability to be successfully managed with a higher active vitamin D dose.
- •? If the subject is treated with active vitamin D in conjunction with calcium supplements, the subject must be taking =0.25 µg/day of calcitriol or =0.5 µg of
- •alfacalcidol with =1000 mg/day of calcium supplement. If the subject is treated with <0.25 µg/day of calcitriol or <0.5 µg of alfacalcidol or <1000 mg/day of calcium supplement, the subject must have a history of inability to be successfully managed
- •on higher doses of at least one of these supplements
- •9. Has thyroid-stimulating hormone (TSH) results within normal laboratory limits at screening for all subjects not receiving thyroid hormone replacement therapy. For subjects on thyroid hormone replacement therapy, the thyroid hormone dose must have been stable for at least 4 weeks before screening, and serum TSH level must be within the
- •central laboratory normal range. A serum TSH level below the lower limit of the normal range but not undetectable in subjects treated with thyroid hormone may be allowed if there is no anticipated need for a change in thyroid hormone dose during the trial.
- •10. Has serum 25-hydroxyvitamin D levels =50 mmol/L (20 ng/mL) and <1.5 times the upper limit of normal (ULN) for the central laboratory normal range.
- •11. Has estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2.
- •12. Prior to randomization, is able to perform daily SC self-injections of study medication (or have a designee perform injection) via a multidose injec
排除标准
- •1. History of hypoparathyroidism resulting from a known activating mutation in the CaSR gene or impaired responsiveness to PTH (pseudohypoparathyroidism).
- •2. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism; Paget disease; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus; severe and chronic cardiac, liver, or renal disease; Cushing syndrome; rheumatoid arthritis; myeloma; active
- •pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy (other than low-risk well differentiated thyroid cancer); primary or secondary hyperparathyroidism; or documented parathyroid carcinoma within the previous 5 years,
- •acromegaly, or multiple endocrine neoplasia types 1 and 2.
- •3. Albumin-corrected serum calcium level <1.875 mmol/L (7.5 mg/dL) or =2.56 mmol/L (10.3 mg/dL) at the Week -3screening visit. Results from a local laboratory may be used for this assessment.
- •4. Albumin-corrected serum calcium level =2.56 mmol/L (10.3 mg/dL) at the baseline (Week 0) visit. Results from a local laboratory may be used for this assessment.
- •5. Use of prohibited medications, such as loop and thiazide diuretics, phosphate binders (other than calcium carbonate), digoxin, lithium, methotrexate, or systemic corticosteroids, within respective prohibited periods. See Section 5 (Prior and Concomitant Treatment) for a list of prohibited and restricted medications
- •6. Participation in any other investigational study in which receipt of investigational drug or device occurred within 6 months before screening for this study. Prior treatment with PTH-like drugs (whether commercially available or through participation in an
- •investigational study), including PTH(1-84), PTH(1-34), or other N-terminal fragments or analogs of PTH or PTH-related protein, within 3 months before screening.
- •7. Use of other drugs known to influence calcium and bone metabolism, such as calcitonin, fluoride tablets, or cinacalcet hydrochloride, within the prohibited period.
- •8. Use of oral bisphosphonates within the previous 6 months or intravenous bisphosphonate
- •preparations within the previous 24 months before screening.
- •9. Nonhypocalcemic seizure disorder with a history of a seizure within the previous 6 months before screening. Subjects with a history of seizures that occur in the setting of hypocalcemia are allowed.
- •10. The subject is at increased baseline 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 external beam or implant radiation therapy involving the skeleton.
- •11. Any disease or condition that, in the opinion of the investigator, may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- •12. Pregnant or lactating women.
- •13. History of diagnosed drug or alcohol dependence within the previous 3 years.
- •14. 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 disease.
- •15. Chronic or severe cardiac disease including but not limited to heart failure, arrhythmias, bradycardia (resting heart rate <50 beats/minute).
- •16. History of cerebrovascular accident.
研究者
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