NL-OMON51487招募中3 期
An Open-Label Extension Study of AKCEA-APOCIII-LRX Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS) - ISIS 678354-CS13 OLE
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5
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 99（—）
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. Satisfactory completion of the ISIS 678354-CS3 index study (last dose as
- •scheduled at Week 49) with an acceptable safety profile, per Investigator
- •3. Willing to follow a diet comprising <= 20 g fat per day during the study
- •4. Satisfy the following:
- •a. Females: must be non-pregnant and non-lactating and either:
- •i. surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral
- •salpingectomy,
- •bilateral oophorectomy)
- •ii. postmenopausal (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 follicle-stimulating hormone (FSH)
- •levels in the postmenopausal range for the laboratory involved)
- •iii. abstinent* or
- •iv. if engaged in sexual relations of child-bearing potential, agree to use a
- •effective contraceptive method from the time of signing the informed consent
- •form until at least 30 weeks after the last dose of ISIS 678354
- •b. Males: Surgically sterile, abstinent* or if engaged in sexual relations with
- •a female of
- •child-bearing potential, agree to use a highly effective contraceptive method
- •time of signing the informed consent form until at least 30 weeks after the
- •last dose of
- •ISIS 678354
- •* Abstinence is only acceptable as true abstinence, i.e., when this is in line
- •preferred and usual lifestyle of the patient. Periodic abstinence (e.g.,
- •ovulation, symptothermal, post-ovulation methods), declaration of abstinence for
- •the duration of a trial, and withdrawal are not acceptable methods of
- •contraception
- •5. The following concomitant medications will be allowed if dosing regimen is
- •expected to
- •remain constant through the end of the study (occasional or intermittent use of
- •over-the-counter (OTC) medications will be allowed at Investigator*s
- •discretion):
- •a. Statins, omega-3 fatty acids (prescription and OTC), fibrates, or other
- •lipid-lowering
- •medications. Patients taking OTC omega-3 fatty acids should make every effort to
- •remain on the same brand through the end of the study
- •b. Antidiabetic medications except glucagon-like peptide 1(GLP-1) agonist that
- •is disallowed
- •c. Antihypertensive medications
- •d. Oral anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, and apixaban)
- •regular clinical monitoring is performed
- •e. Tamoxifen, estrogens or progestins
- •f. Atypical antipsychotic medications (e.g., olanzapine and clozapine)
排除标准
- •1. Have any new condition or worsening of existing condition which in the
- •opinion of the
- •Investigator would make the patient unsuitable for enrollment, or could
- •interfere with the
- •patient participating in or completing the study, including need for treatment
- •medications disallowed in the index study (ISIS 678354-CS3).
研究者
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