EUCTR2017-002165-21-GR进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ISIS 416858 (IONIS-FXIRX an Antisense Inhibitor of Factor XI), Administered Subcutaneously to Patients with End-Stage Renal Disease on Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 204
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 aged 18 to 85 years old at the time of informed consent
- •a Females: must be non-pregnant and non-lactating and either:
- •i. surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy);
- •ii. 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); or,
- •iii. if engaged in sexual relations and of child-bearing potential, agree to use 2 highly effective contraceptive methods from the time of signing the informed consent form until at least 84 days (approximately 5 half-lives of ISIS 416858) after the last dose of Study Drug (ISIS 416858 or placebo).
- •b Males: Surgically sterile or if engaged in sexual relations with a female of child-bearing potential, subject is utilizing an acceptable contraceptive method from the time of signing the informed consent form until at least 84 days (approximately 5 half-lives of ISIS 416858) after the last dose of Study Drug (ISIS 416858 or placebo).
- •3. End-stage renal disease maintained on outpatient hemodialysis at a healthcare center for > 3 months from screening with hemodialysis at least 3-times per week for a minimum of 9 hours per week of prescribed treatment time and plan to continue this throughout the study.
- •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 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Subjects with a history of a major medical event (e.g., previous acute coronary syndrome, stroke or transient ischemic attack, or systemic thromboembolic event) within 3 months of screening, major surgery within 3 months of screening, or new major physical examination finding (not accounted for by past medical history), except for documented atrial fibrillation.
- •2. Active bleeding (as judged clinically significant by the Investigator) within the past 3 months from screening or documented bleeding diathesis (excluding uremia), coagulopathy, or recent history of prolonged compression time at arteriovenous fistula.
- •3. Screening laboratory results as follows:
- •Platelet count < 150,000 cells/mm3
- •< 180,000 cells/mm3 for platelet function/activation subgroup
- •INR > 1.4
- •aPTT > upper limit of normal (ULN)
- •ALT or AST > 2 x ULN
- •Total bilirubin > ULN
- •4. Subject is not willing to have weekly subcutaneous injections over the study period as assessed during screening.
- •5. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1 (first dose) or IV antibiotic use at the time of screening.
- •6. Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
- •7. Known history of or positive test at Screening for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B.
- •8. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated. Subjects 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 (or designee).
- •9. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational agent, whichever is longer.
- •10. Any history of previous treatment with an oligonucleotide (including siRNA). Subjects that have previously received only a single dose of an ISIS-oligonucleotide as part of a clinical study may be included as long as a duration = 4 months has elapsed since dosing.
- •11. Attending nephrologist answers no to the question, Would you be surprised if this patient died in the next year?
- •12. Within 6 months prior to screening,
- •More than 3 episodes of severe hypoglycemia requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions
- •One (1) event of hypoglycemia in which the patient required hospitalization
- •Recurrent syncope and recurrent hypotension in the inter-dialytic period requiring intervention
- •13. Planned major surgery in the next 6 months, including subjects receiving a kidney transplant or subjects that anticipate changing dialysis modality (i.e. hemodialysis to peritoneal dialysis).
- •14. Recent history of, or current drug or alcohol abuse as determined by the Investigator
- •15. Concomitant use of anticoagulant/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, clopidogrel) that may affect coagulation (except low dose aspirin (= 100 mg/day) during Treatment and Post-treatment Evaluation Periods is not allowed. Stable doses of heparins during dialysis are permitted.
- •For a subgroup of subjects (approximately 36) being evaluated for platelet function/activation, the concomitant use of
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