EUCTR2011-001826-61-HU进行中（未招募）不适用
A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
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
- •GHDA subjects, males and females, of age between 23 and 65 years with
- •childhood or adult onset, as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone use in Growth Hormone-Deficient Adults and Transition Patients (2009).
- •rhGH drug naive or any registered or investigational rhGH replacement therapy was not given for more than 6 months before the screening.
- •Patients on stable hormonal replacement therapies for deficiencies of other hypothalamo-pituitary axes must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening. Temporary adjustment of glucocorticoid replacement therapy, as appropriate,is acceptable.
- •Screening IGF-I level of at least 1 SD (IGF-I SDS<- 1) below the mean IGF-I level standardized for age and sex according to the central laboratory reference values.
- •Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2.
- •Fertile females must agree to use appropriate contraceptive methods during the study and 20 days after the last dose of study medication.
- •Female patients must have a negative serum pregnancy test at inclusion.
- •Confirmed to be negative for anti rhGH antibodies at the time of screening.
- •Willing and able to provide written informed consent prior to performing any study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Evidence of growth of pituitary adenoma or other intracranial tumor
- •within the last 12 months which has to be confirmed by computer
- •tomography (CT) or magnetic resonance imaging (MRI) scan (with
- •contrast) within 3 months prior to screening. (Patients with inactive
- •remnant intracranial tumors are eligible).
- •History of malignancy other than i) cranial tumor or leukemia causing
- •GHD or ii) fully treated basal cell carcinoma or evidence of active
- •malignancy.
- •Current antitumor therapy.
- •Subjects presenting with any clinically significant ECG abnormality.
- •Evidence of intracranial hypertension.
- •Significant hepatic dysfunction (persistent elevation of alanine
- •transaminase [ALT] or aspartate transaminase [AST] >1.5 x upper limit
- •of normal).
- •Significant renal impairment as indicated by serum creatinine levels
- •above the normalized range for age.
- •Any other major medical conditions, including e.g., clinically manifest
- •diabetes mellitus, hypertension, tuberculosis, major surgery within the
- •last three months before screening, or significantly abnormal laboratory
- •tests (e.g., disturbed calcium homeostasis); or any other conditions
- •(e.g., acute infections) that may influence drug absorption, metabolism
- •or excretion or that may interfere with any study variables in the
- •judgment of the investigator.
- •Systemic corticosteroids other than in replacement doses within the 3
- •months before screening. (Temporary adjustment of glucocorticoids, as
- •appropriate, is acceptable).
- •Pregnancy and breastfeeding
- •Anabolic steroids other than gonadal steroid replacement therapy within 2 months before screening. Per-oral estrogen replacement and
- •contraceptives are not allowed. For replacement purposes, transdermal
- •estrogens are permitted in female patients.
- •History of non-compliance with medications, un-cooperativeness or
- •alcohol/drug abuse.
- •Positive results from serology examination for HBV, HCV or HIV.
- •Known or suspected hypersensitivity to the study treatment.
- •Blood donation or any major blood loss >500 mL within the past 90 days
- •prior to screening.
- •History of any medical or psychiatric condition that in the opinion of the
- •investigator would pose a risk for participation in this study or interfere
- •with the compliance needed for this study.
- •Received an investigational drug or product, or participated in a drug
- •study within 30 days before Screening.
研究者
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