NL-OMON55679已完成3 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)] - SHP634-401
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
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
- 18 至 99（—）
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 18-25 years of age, has radiological evidence of epiphyseal
- •closure based on bone age X-ray (single posteroanterior X-ray of left wrist and
- •5. Has chronic 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. The subject must have a Hypoparathyroidism Symptom
- •Diary (HPT-SD) symptom subscale Sum Score of >=10 during the 14-day period
- •immediately prior to the baseline (Week 0) visit (Day -14 to Day -1). In
- •addition, the subject must have at least 4 HPT-SD diaries completed in the
- •first 7 day period and at least 4 HPT-SD diaries completed in second 7 day
- •period. See Appendix 3 for the calculation of the sum score., 8. Must be
- •treated with active vitamin D (calcitriol or alfacalcidol) alone or in
- •conjunction with calcium supplements for at least 4 months prior to the
- •screening visit.
- •The subject must be taking >=0.5 µg/day of calcitriol or >=1.0 µg/day of
- •alfacalcidol.
- •If the subject is treated with a lower dose of active vitamin D the subject
- •must also be taking calcium supplements of at least 800 mg/day of elemental
- •calcium, 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 the 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 nmol/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 injection pen
- •into the thigh., 13. Willing to use oral active vitamin D and calcium
- •supplements provided for the study unless directed to remain on the supplements
- •used prior to enrollment in the current study by the investigator after
- •consultation with the medical monitor., 14. With regard to female subjects:
- •women who are postmenopausal (12 consecutive months of spontaneous amenorrhea
- •and age more than or equal to 51 years) and women who are surgically sterilized
- •can be enrolled. Wo
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 poorly controlled
- •hyperthyroidism; Paget disease; type 1 diabetes mellitus or poorly controlled
- •type 2 diabetes mellitus; severe and chronic cardiac, liver (Child-Pugh score
- •>9) (US FDA, 2003), 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. Very low or very high blood calcium level (eg, ACSC <1.87 mmol/L [<7.5
- •mg/dL] or >=2.97 mmol/L [>=11.9 mg/dL]) at the Week -3 screening visit. Results
- •from the central laboratory must be used for this assessment.
- •4. If the Blood calcium level is above the ULN at the baseline (Week 0) visit,
- •the analysis can be repeated another day as long as the next date is within the
- •visit window for the baseline visit. If the subject does not met exclusion #4
- •on the repeat measure the subject may be randomized., 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. For example, illness
- •that is anticipated to be chronic and not transient., 12. Pregnant or lactating
- •women., 13. Known or suspected intolerance o
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