EUCTR2017-004259-22-AT进行中（未招募）1 期
A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS GHR-LRX, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients with Acromegaly Being Treated with Long-acting Somatostatin Receptor Ligands (SRL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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.Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
- •2.Males or females with documented diagnosis of Acromegaly*. Aged 18 to 75 years old (inclusive) at the time of informed consent
- •*Defined as a previous diagnosis of GH-secreting adenoma by surgical pathology; or the presence of a pituitary adenoma on magnetic resonance imaging (MRI) and serum IGF-1 levels above the upper limit of normal for age and sex at time of diagnosis (serum IGF-1 level and MRI at diagnosis will be collected in the CRF)
- •3.Patients must be on stable maximum or maximally tolerated dose of SRL (lanreotide Autogel or octreotide LAR, per treating physician judgment) every 28 days for a minimum of 3 months prior to screening and will be required to continue their stable dose of SRL throughout the study. In accordance with US approved prescribing information, the maximal dose recommended per the package insert for lanreotide Autogel is 120 mg every 28 days and for octreotide LAR is 40 mg every 28 days (the reason for the maximally tolerated dose of SRL will be collected in the CRF). SRL dose should not exceed the maximum dose as approved in the local region (as indicated in the SRL label). Prior use of other medications for treating acromegaly (pasireotide, dopamine agonist or pegvisomant) is allowed but not within 6 weeks of screening
- •4.At Screening, serum IGF-1 (performed at central lab) between 1.3 to 5 x ULN, inclusive, adjusted for age and sex
- •5.Females must be non-pregnant and non-lactating, and either
- •a.surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
- •b.post-menopausal (defined as 12 months of spontaneous amenorrhea in females
- •> 55 years of age or, in females = 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved)
- •c.abstinent or
- •d.Women of childbearing potential (WOCBP) should agree to taking all precaution to avoid pregnancy during the trial period (including Post-Treatment), including agreeing to receive pregnancy testing before each monthly dose, using 1 highly effective method of birth control (Section 6.3.1) from the time of signing the informed consent form until 14 weeks after the last dose of Study Drug administration
- •Males must be surgically sterile, abstinent or, if engaged in sexual relations with a female of child-bearing potential, the patient or the patient’s non-pregnant female partner must be using 1 highly effective contraceptive method (refer to Section 6.3.1) from the time of signing the informed consent form until 14 weeks after the last dose of Study Drug.
- •6.Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) for at least 24 hours prior to study visits
- •7.Willing to refrain from alcohol or tobacco use for 8 hours prior to study visits
- •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 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1.Clinically-significant abnormalities in medical history (e.g., previous acute coronary syndrome within 6 months of screening, major non-pituitary surgery within 3 months of screening) or from screening physical examination
- •2.Patients who received surgery for pituitary adenoma within the last 6 months before the trial, and/or planning to receive surgery during the trial
- •3.Patients who received radiotherapy for pituitary adenoma within the last 3 years before the trial, and/or planning to receive radiotherapy during the trial
- •4.Patients with a pituitary tumor that, per Investigator judgment, is worsening (e.g., either growing, or at risk of compressing or abutting the optic chiasm or other vital structures) as assessed by pituitary/sellar MRI protocol at Screening or within 6 months of screening
- •5.Evidence of decompensated cardiac function per medical judgement and/or NYHA class 3 or 4
- •6.Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment
- •7.Symptomatic cholelithiasis, and/or choledocholithiasis
- •8.Have a diagnosis of Gilbert’s disease
- •9.Patients with history of hypoglycemia unawareness (who have had > 3 severe episodes in the past 6 months) or documented reactive hypoglycemia
- •10.Screening laboratory results as follows, or any other clinically-significant abnormalities in screening laboratory values that would render a patient unsuitable for inclusion. (abnormalities may be retested for eligibility purposes)
- •a.Urine protein/creatinine (P/C) ratio = 500 mg/g. In the event of P/C ratio above this threshold eligibility may be confirmed by a quantitative total urine protein measurement of < 1000 mg/24 hr
- •b.Positive test (including trace) for blood on urinalysis. In the event of a positive test eligibility may be confirmed with urine microscopy showing < 5 red blood cells per high power field
- •c.ALT or AST > 1.2 x ULN, bilirubin > ULN; alkaline phosphatase (ALP) > 3 x ULN
- •d.eGFR < 45 mL/min/1.73m2 as determined by the Chronic Kidney Disease-Epidemiological Collaboration (CKD-EPI) equation for creatinine clearance OR serum creatinine > 1.8 mg/dL in males and > 1.5 mg/dL in females
- •e.Platelet count < LLN
- •f.Abnormal thyroid function tests must be approved by the Sponsor Medical Monitor
- •g.HbA1c > 10%
- •h.Morning (prior to 9 AM) blood cortisol < 10 mcg/dL (280 nmol/L)
- •11.Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
- •12.Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
- •13.Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- •14.Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, follicular Stage 1 or papillary thyroid cancer that has been successfully treated; patients with a history of other malignancies that have been treated with curative intent and which have no recurrence within 5 years may also be eligible if approved by the Sponsor Medical Monitor
- •15.Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent, whichever is longer
- •16.Treatment with any non- ION- or ISIS-oligonucleotide (including siRNA) at any time or prior treatment with an ION- or ISIS-oligonucleotide within 9 months
研究者
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