EUCTR2016-001275-80-DE进行中（未招募）1 期
An Open-Label Study of XOMA 358, with Optional Dose Escalation, in Patients with Congenital Hyperinsulinism
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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.Provide written informed consent and, as applicable, assent, before any study specific procedures are performed
- •2.Aged 12 to 65 years at Screening
- •3.Body mass index < 35 kg/m2 for patients aged 18 years and above and, for patients aged less than 18 years, BMI < 95% percentile for age
- •4.An established clinical diagnosis, with or without a genetic diagnosis, of congenital hyperinsulinism
- •5.Documented hypoglycemia (blood glucose < 60 mg/dL [< 3.33 mM]) during 2 monitored fasts during screening. Patients with blood glucose levels = 60 mg/dL (= 3.33 mM) but who demonstrate a clinically meaningful decrease in blood glucose in conjunction with symptoms during the monitored fasts may be enrolled upon discussion and agreement between the Investigator and the Sponsor.
- •6.In the opinion of the Investigator, can be safely washed out of background medications used to treat HI
- •7.Hepatic ultrasound at Screening without clinically significant findings or evidence of peliosis hepatis
- •8.For female patients of childbearing potential, a negative serum pregnancy test
- •9.For female patients with reproductive potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile), a willingness to use highly effective* contraceptive measures adequate to prevent a new pregnancy for at least 3 months after administration of study drug. For women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended.
- •(*Highly effective methods of birth control are defined as those that alone or in combination result in a low failure rate [ie, less than 1% per year] when used consistently and correctly [eg, implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal occlusion, true sexual abstinence in line with the preferred and usual lifestyle of the patient, or vasectomized partner.])
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any out-of-range laboratory value at Screening that has not been reviewed, approved, and documented as not clinically significant by the Investigator, except for the following liver function test exclusions:
- •- total bilirubin = 1.5X upper limit of normal
- •- ALT, AST, or ALP = 2X upper limit of normal
- •2.Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or ß agonists, that may affect glucose metabolism. Such agents will be washed out before dosing. Topical, inhaled, and intranasal corticosteroids at doses that are unlikely to affect glucose homeostasis and corticosteroids for ophthalmic use are permitted.
- •3.Use of any long-acting somatostatin analogs or glucose-affecting medications that require > 72 hour washout
- •Note: Patients who are on a stable dose and regimen of a long-acting somatostatin analog and meet inclusion criterion number 5 for hypoglycemia during Screening may remain on such treatment and be enrolled into the study upon discussion and agreement between the Investigator and the XOMA Medical Monitor.
- •4.History of malignancy within 3 years before Screening other than carcinoma in situ of the cervix or adequately treated nonmetastatic squamous or basal cell carcinoma of the skin.
- •5.History of seropositivity for HIV antibody, hepatitis B, or hepatitis C antibody
- •6.Major general surgery within 3 months before Screening or anticipated during the study period
- •7.Known allergy or sensitivity to XOMA 358 or any component of the study drug
- •8.Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug before Day 1, whichever is longer. Participation in registries and purely diagnostic studies is allowed.
- •9.Female patients who are pregnant, planning to become pregnant during the course of the study, have recently delivered (within 3 months before Screening), or are breast-feeding
- •10.Male patients who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug
- •11.Any organ condition, concomitant disease (eg, psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study (eg, may affect absorption, distribution, metabolism, or elimination of the study drug) or that, in the opinion of the Investigator and/or Sponsor’s medical monitor, would pose an unacceptable risk to the patient in the study.
研究者
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