CTIS2023-507413-10-00招募中1 期
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of OMS906 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - OMS906-PNH-003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Omeros Corp.
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Have completed the last dosing visit of the prior OMS906 PNH studies. Patients who have tolerated OMS906 well and had an adequate clinical response will be eligible., Female patients of child-bearing potential (CBP) must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906., Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug; If a female, must be sterile (either surgically or biologically)* or at least one year postmenopausal**, or have a monogamous partner who is surgically sterile, or have a same sex partner, or if in a heterosexual relationship, must agree to comply with the following contraception guidelines: Practice abstinence (only considered an acceptable method of contraception when it is in line with the patients’ usual and preferred lifestyle and the patient agrees to refrain from heterosexual intercourse during the entire period of risk associated with the study treatments, including during the clinical trial and for 20 weeks [140 days] following their last dose of study drug), or Use at least 1 of the following medically acceptable methods of birth control: hormonal methods (combined estrogen-andprogestogen- containing hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal] or progestogen only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable]), intrauterine devices, intrauterine hormone-releasing systems, bilateral salpingectomy or bilateral tubal ligation/occlusion, or a vasectomized partner. * Defined as having had a hysterectomy and/or bilateral oophorectomy at least 6 weeks prior to the Evaluation Period; or have a congenital or acquired condition that prevents child-bearing. ** Defined as at least 12 months with no menses without an alternative medical cause (confirmed with follicle stimulating hormone level [FSH] in the postmenopausal range [FSH levels = 40 mIU/mL during the Evaluation Period] if the patient is not using hormonal contraception or on hormonal replacement therapy). In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient., Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug that include the following: Practice abstinence (only considered an acceptable method of contraception when it is in line with the patients’ usual and preferred lifestyle and the patient agrees to refrain from heterosexual intercourse during the entire period of risk associated with the study treatments, including during the clinical trial and for 20 weeks [140 days] following their last dose of study drug), or Use (or have their partner use) acceptable highly effective contraception (see Criterion #3) during heterosexual activity., Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Haemophilus influenza (for S. pneumoniae and H. influenzae, if locally available and/or part of standard of care) and agree to maintain vaccination throughout the study., Have provided informed consent.
排除标准
- •Platelet count < 30,000/µL or absolute neutrophil count < 500 cells/µL at the start of the Evaluation Period., Elevation of liver function tests, defined as total bilirubin > 2 × ULN, direct bilirubin > 1.5 × ULN, and elevated transaminases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST), > 2 × ULN unless due to PNH-related hemolysis., History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation., Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis., Pregnant, planning to become pregnant, or nursing female patients., History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the Investigator would make the patient unsuitable for participation in the long-term extension study., Unable or unwilling to comply with the requirements of the study.
研究者
相似试验
进行中（未招募）
1 期
Open-Label Study of Long-Term Safety and Efficacy of Lanadelumab forPrevention of Acute Attacks of Non-histaminergic Angioedema withNormal C1-Inhibitornon-histaminergic angioedema with normal C1-INHMedDRA version: 20.0Level: HLTClassification code 10002425Term: AngioedemasSystem Organ Class: 100000004858EUCTR2019-004823-20-HUTakeda Development Center Americas (TDCA)75
进行中（未招募）
1 期
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA)Angelman SyndromeMedDRA version: 20.0Level: PTClassification code 10049004Term: Angelman's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2019-004478-24-NLOvid Therapeutics Inc.200
进行中（未招募）
1 期
Open-Label Study of Long-Term Safety and Efficacy of Lanadelumab forPrevention of Acute Attacks of Non-histaminergic Angioedema withNormal C1-InhibitorEUCTR2019-004823-20-DETakeda Development Center Americas (TDCA)75
进行中（未招募）
1 期
ong-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticityEUCTR2017-004101-40-BGOsmotica Pharmaceutical US LLC300
进行中（未招募）
1 期
ong-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticitySpasticity in patients with multiple sclerosisMedDRA version: 20.0Level: LLTClassification code 10041416Term: SpasticitySystem Organ Class: 100000004852EUCTR2017-004101-40-PLOsmotica Pharmaceutical US LLC300