EUCTR2012-004975-37-DE进行中（未招募）1 期
A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency
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
- 52
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
- •1.) Patient agrees to provide written informed consent and to comply with the study protocol after reading the informed consent and discussing the study with the investigator.
- •2.) Males and females between 23 and 65 years of age must have a confirmed diagnosis of adult GHD, either adult onset (AO) GHD due to hypothalamic-pituitary disease or childhood onset (CO) GHD that is either idiopathic or due to hypothalamic-pituitary disease or due to genetic causes.
- •3.) Diagnosis of GH deficiency must be confirmed by documented (medical records) diagnostic testing specified by an accepted guidance (e.g., GH Research Society Consensus guidelines for the diagnosis and treatment of adults with GH deficiency 2007; AACE Clinical Practice Guidelines 2009; Endocrine Society Clinical Practice Guidelines Molitch et.al. 2006 and 2011) in effect at the time of
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.)Patients with history or clinical evidence of active or chronic diseases
- •that could confound results of the study or put the subject at undue risk
- •as determined by the investigator.
- •2.) Patients with known active malignancy
- •3.) Patients with history of malignancy other than intracranial tumor
- •causing GHD (excluding surgically cured basal cell or squamous cell
- •cancer of the skin with documented 6 month remission)
- •4.) Patients with a new diagnosis of pituitary adenoma or other
- •intracranial tumor within 12 months of baseline (Visit 3)
- •5.) Presence of Prader-Willi syndrome, Turner's syndrome, untreated
- •adrenal insufficiency, active acromegaly in the past 5 years, or active
- •Cushing's syndrome in the past 1 year.
- •6.) Patients with known history of severe allergic or anaphylactic
- •7.) Patients with known allergy or hypersensitivity to rhGH, HSA, yeastderived
- •products, or any other component of the formulation
- •8.) Patients with antibodies to hGH following the washout period.
- •9.) Patients who will require a dose of the study drug (TV-1106) in
- •excess of 50 mg/week or of Genotropin® in excess of 1.8 mg/day at
- •baseline visit.
- •10.) Patients who have had 1 of the following conditions in the noted
- •amount of time prior to screening or between screening and first dosing
- •day: major trauma or surgery within 6 months; acute infection requiring
- •systemic antibiotic treatment within 4 weeks; any acute, severe illness
- •within 6 months
- •11.) Patients with history of documented increased intracranial pressure
- •(ICP) associated with GH treatment or signs of increased ICP including
- •papilledema based on fundoscopic exam performed by investigator or
- •ophthalmologist during screening.
- •12.) Patients who have participated in another clinical trial with a new
- •chemical/biological entity within 3 months of screening
- •13.) Patients who have clinically significant abnormal electrocardiogram
- •(ECG) as determined by the investigator
- •14.) Patients with untreated or poorly controlledhypertension, and patients with Stage 2 hypertension (SBP>=160mmHg and/or DBP>=100(as defined in JNC, 2004)).
- •15.) Patients with abnormal levels [greater than x2 the upper limit of normal (ULN)] of alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT) or total bilirubin at screening.
- •16.) Patients with known history of or confirmed positive test results for
- •human immunodeficiency virus (HIV) types 1 and 2 at screening
- •17.) Patients with known Hepatitis B or Hepatitis C infection.
- •18.) Patients using weight reducing agents or appetite suppressants.
- •19.) Patients with persistent or recurring migraines, clinically important edema carpal tunnel syndrome, paresthesias, or other nerve compression symptoms as assessed by the investigator.
- •20.) Patients with known diagnosis of diabetes or pre-deabetes (impaired fasting glucose) as defined in the American Diabetes Association position statement (ADA, 2013)
- •21.) Women who are pregnant or nursing at the time of screening or
- •who intend to be during the study period.
- •22.) Patients who use anabolic steroids or corticosteroids except for
- •physiological maintenance doses used as treatment for patients with
- •hormone deficiencies. Limited use of low dose glucocorticoid
- •preparations is allowed (eg. skin creams, eyedrops).
- •Inhaled budesonide will be permitted at a monthly consumption not to
- •exceed 400 µg/day for 3 days (total 1200 µg/month).
- •23.) Patients with a malignant appearing skin lesion unless i
研究者
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