NCT02152228已完成2 期
A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is an observational, international, open label, pilot study to evaluate the safety, tolerability and efficacy of an oral PTH (1-34) preparation produced by Entera Bio in adult hypoparathyroid volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of primary hypoparathyroidism for more than 1 year.
- •Currently taking >1.0 grams of Calcium/day with a correlate alpha D3 dose.
- •25(OH)D levels ≥ 20 ng/ml.
- •Signed informed consent.
- •BMI 18 - 30 kg/m2, inclusive.
- •Full blood count should be within the reference range as per WHO criteria. Minor abnormalities will be assessed by the Principle Investigator and after discussion with sponsor patients may still be entered if these are felt to be of "no clinical importance". Abnormalities due to hypoparathyroidism related are acceptable and will not constitute exclusion.
- •Patients with significant liver function impairment (liver enzymes above x3 the upper limit of normal range as per WHO criteria) will be excluded.
- •Subjects able to adhere to the visit schedule and protocol requirements.
排除标准
- •Haemoglobin <12 g/dL (females)/ <13gm/dL (males) [lower limit of reference range 12-15 & 13-17]
- •Impaired renal function
- •impaired liver function; ALT >38 international units per liter (IU/L), or ALP>125 IU/L
- •Significant drug or alcohol abuse as assessed by the Principal Investigator
- •Allergy to soy bean products
- •Presence of kidney or urinary tract stones
- •Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- •Treatment with any investigational product within the last 30 days, enrollment or intention to enroll in any active study involving the use of investigational devices or drugs.
- •Presence of any other condition or circumstance that, in the judgment of the Investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- •Active infections
- •Pregnancy or suspected pregnancy. Female subjects must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control (reliable use of oral contraceptive, non-hormonal intrauterine device with condom, or diaphragm with condom, or condom with spermicide) from the screening visit through the study termination visit or declare that they are abstaining from sexual intercourse from the screening visit through the study termination visit or are surgically sterile (have undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.
研究组 & 干预措施
Oral Parathyroid Hormone (1-34)
Experimental
Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34)
干预措施: EnteraBio's Oral Parathyroid Hormone (1-34) (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: up to 17 weeks
safety will be measured by monitoring and recording adverse events related to hyper- and hypocalcemia
Reduction in use of exogenous calcium supplement and/or alpha D3 supplement
时间窗: up to 17 weeks
Tolerability- The rate of discontinuation of patients' participation in the study due to adverse events
时间窗: up to 17 weeks
Peak Plasma Concentration (Cmax)of treatment
时间窗: at baseline and time-points post-dose
To study the pharmacokinetic profile of PTH absorption
Plasma calcium levels
时间窗: at baseline and 60 minutes post-dose
次要结局
- Patient quality of life(up to 17 weeks)
- The volunteers' compliance to treatment(up to 17 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne ScarsAtrophic Acne ScarsNCT02643628Suneva Medical, Inc.45
撤回
1 期
A Study to Investigate the Safety and Efficacy of a Novel Furosemide RegimenAcute Decompensated Heart FailureNCT02721511Todd M Koelling, MD
已完成
3 期
CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in AdultsAttention Deficit Disorder With HyperactivityNCT00246207Janssen-Ortho Inc., Canada32
已完成
早期 1 期
Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT01843634Chimerix10
已完成
不适用
Pilot LDE225 in Locally Advanced or Metastatic BCC + Previously Tx Non-LDE225 Smoothened InhibitorsBasal Cell CarcinomaNCT01529450Anne Chang11