EUCTR2015-002847-32-GB进行中（未招募）1 期
A Single-Dose Open-Label Study of XOMA 358 in Subjects with Congenital Hyperinsulinism (HI)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
入选标准
- •1. Provide written informed consent and, as applicable, assent, before any study-specific procedures are performed
- •2. Aged at least 12 years at Screening
- •3. An established clinical diagnosis, with or without a genetic diagnosis, of congenital hyperinsulinism
- •4. Duration of glucose levels < 70 mg/dL, by CGM, for an average of at least
- •120 minutes across baseline Days -3, -2, and -1 with no single duration < 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment
- •5. In the opinion of the Investigator, can be safely washed out of background HI medications
- •6. Hepatic ultrasound at Screening without clinically significant findings or evidence of peliosis hepatis
- •7. For female subjects of childbearing potential, a negative serum pregnancy test
- •8. For females subjects of childbearing potential and male subjects with a female partner of childbearing potential, a willingness to use contraceptive measures adequate to prevent the subject or subject’s partner from becoming pregnant during the study and for at least 4 months after the administration of study drug.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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, with the exception of liver function tests for total bilirubin, ALT, AST, and ALP, which must be within 1.5X the upper limit of normal (UNL) for the reference range
- •2. During confinement, 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 after checking-in to the in-patient research facility and before dosing. Topical, inhaled, and intranasal corticosteroids at doses that are unlikely to affect glucose homeostasis and corticosteroids for ophthalmic use are permitted.
- •3. Body Mass Index = 35 kg/m2
- •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 subjects 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 subjects 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 subject in the study.
研究者
相似试验
进行中（未招募）
1 期
A non-blinded study of XOMA 358, with a possibility to increase the dose, in patients with abnormal levels of insulin due to a genetic dysfunctioHypoglycemia associated with congenital hyperinsulinismMedDRA version: 19.0Level: LLTClassification code 10077227Term: Hyperinsulinemic hypoglycemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 19.0Level: LLTClassification code 10020644Term: Hyperinsulinism NOSSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 19.0Level: PTClassification code 10061211Term: HyperinsulinismSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 19.0Level: LLTClassification code 10022484Term: Insulin hypoglycaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2016-001275-80-DEXOMA (US) LLC
进行中（未招募）
1 期
A Phase 3 Study Comparing LOXO-305 to Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus RituximabChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaMedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864EUCTR2020-004554-30-HRoxo Oncology Inc250
进行中（未招募）
1 期
A Phase 3 Study Comparing LOXO-305 to Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus RituximabChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaMedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864EUCTR2020-004554-30-CZoxo Oncology Inc250
招募中
3 期
A Phase 3 Study of LOXO-305 in Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaJPRN-jRCT2021210031Shahda , MD Safi10
进行中（未招募）
1 期
A clinical study to assess the effectiveness and safety of LOXO-305 compared to standard of care treatment chosen by the Investigator in patients with previously treated Mantle Cell LymphomaMantle cell lymphomaMedDRA version: 20.0Level: LLTClassification code 10026799Term: Mantle cell lymphoma NOSSystem Organ Class: 100000004864EUCTR2020-004553-72-DKoxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company500