jRCT2051240158招募中不适用
A Phase 3 multiCenter, rAndomized, pLacebo-controlled, double blind studY to evaluate the efficacy and safety of eneboparatide (AZP-3601), a Parathyroid hormone receptor agoniSt, in patients with chronic hypOparathyroidism (CALYPSO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 主要终点
- Complete independence from active vitamin D
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 80age old not（—）
- 性别
- All
入选标准
- •Males and Females, 18-80 years of age
- •Patients with chronic hypoparathyroidism (cHP) for >=12 months at the time of screening
- •Two paired measurements of showing low parathyroid hormone (PTH) and serum calcium either below normal or within normal under standard of care
- •Requirement for therapy with calcitriol >=0.5 mcg per day or alphacalcidol >=1 mcg per day, and requirement for supplemental oral calcium treatment >=1000 mg per day over and above patient's dietary calcium intake at Day 1 visit
- •For the Japan cohort, the following patients will be enrolled;
- •a. Requirement for therapy with calcitriol >=0.5 micro g per day, alfacalcidol >=1 micro g per day, or falecalcitriol >= 0.3 micro g per day, and requirement for supplemental oral (elemental) calcium treatment >=1000 mg per day over and above patient7' dietary calcium intake at Day 1 visit;
- •b. Requirement for therapy with calcitriol >= 1 micro g per day, alfacalcidol >= 2 micro g per day, or falecalcitriol >= 0.6 micro g per day at Day 1 visit (no minimum daily dose limit for oral calcium supplementation);
- •Successful completion of the Optimization period based on two consecutive measurements of albumin-adjusted serum calcium at least 1 week apart within the range of 7.8 to 9.0 mg/dL and with no more than 25% of change in the daily dose of any of active vitamin D and oral calcium supplements between the two measurements
- •Thyroid-stimulating hormone (TSH) within the lower limit of normal and 1.5-fold of the upper limit of normal at screening; if on suppressive therapy for a history of thyroid cancer, TSH level must be >=0.2 mIU/mL and thyroid medication should be stable for at least 6 weeks prior to treatment
- •7.Prior to start of treatment:
- •a. Magnesium level within laboratory normal limits
- •b. 25(OH) vitamin D levels of 30-70 ng/mL (75-175 nmol/L)
- •eGFR >=30 mL/min/1.73m2 during screening
- •Able to perform daily subcutaneous self-injections of study drug (or have a designee to perform injections) via a pre-filled injection pen
- •Female patients of non-childbearing potential or using an effective method of contraception throughout the study. Women of childbearing potential should have a negative pregnancy test.
- •Able and willing to provide written and signed informed consent in accordance with GCP
排除标准
- •Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
- •Clinically significant abnormal values at screening for hematology, clinical chemistry, coagulation or urinalysis
- •Abnormal arterial pressure at screening, defined as (1) systolic blood pressure <100 mmHg, or (2) systolic blood pressure >150 mmHg, and/or diastolic blood pressure >100 mmHg.
- •Heart rate at rest outside the range of 50-100 beats/minute at screening
- •Clinically significant abnormal standard 12-lead electrocardiogram indicative of severe cardiac disease
- •Known history of autosomal-dominant hypocalcemia or known pseudohypoparathyroidism (impaired responsiveness to PTH)
- •Any current disease (other than hypoparathyroidism) that might affect calcium metabolism, calcium-phosphate homeostasis or PTH levels
- •Patients with increased risk for osteosarcoma
- •Current uncontrolled active disease processes that may adversely affect gastrointestinal absorption
- •History of cerebrovascular accident within 6 months prior to screening
- •History of active uncontrolled malignancy over the past 2 years at time of screening
- •History of any other cancer other than thyroid cancer (except basal cell skin cancer or squamous cell skin cancer) who have not been disease-free for a period of at least 2 years at the time of screening
- •Acute gout <2 months prior to screening
- •Dependent on parenteral calcium infusions to maintain calcium homeostasis
- •Use of medications such as loop and thiazide diuretics, raloxifene hydrochloride, lithium, methotrexate, cardiac glycosides or systemic corticosteroids within 4 weeks prior to start of treatment
- •Previous treatment with PTH/parathyroid hormone-related protein-like drugs, including PTH(1-84) and PTH(1-34) within 3 months of screening
- •Use of other drugs known to influence calcium and bone metabolism within 4 weeks of screening
- •Use of oral bisphosphonates within 6 months of screening or intravenous bisphosphonate within 12 months of screening
- •Use of denosumab within 18 months of screening
- •Seizure disorder/epilepsy with history of a seizure within 6 months of screening
- •History of symptomatic urinary tract calculi within 3 months of screening
- •Irradiation to the skeleton within 2 years of screening
- •Pregnant or breastfeeding female patients
- •Participation in any other interventional study in which the patient received an investigational drug or device within 2 months or within 5 times the half-life of the investigational drug (whichever comes first) prior to screening
- •Any disease or condition that, in the opinion of the investigator, may require treatment or make the subject unlikely to fully complete the trial, or any condition that presents undue risk from the study treatment or procedures, including treated malignancies that are likely to recur within the approximate duration of the trial
- •Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule
- •Known allergy or sensitivity to PTH or any of the excipients
结局指标
主要结局
Complete independence from active vitamin D
时间窗: After 24 weeks of treatment
Achieving complete independence from active vitamin D
Independence from therapeutic doses of oral calcium
时间窗: After 24 weeks of treatment
Achieving independence from therapeutic doses of oral calcium (i.e. taking oral elemental calcium supplements <= 600 mg/day)
Albumin-adjusted serum calcium within normal range
时间窗: After 24 weeks of treatment
With albumin-adjusted serum calcium within the normal range (8.3 to 10.6 mg/dL)
次要结局
- Proportion of patients with normalized 24-hour urinary calcium level
研究者
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