PACTR202206488890527尚未招募2 期
A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Characterize the Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients with Sickle Cell Disease
Bausch Health America0 个研究点目标入组 60 人开始时间: 2022年3月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
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
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject must have the ability and willingness to sign a written informed consent form.
- •2.Subject is between the ages of 18 to 70 years old (inclusive) at the time of consent.
- •3.Subject has SCD of any genotype (HbSS, HbSC, HbS ß-thalassemia). If the subject’s
- •genotype has not been previously documented, genotyping will be performed during
- •Screening using high-performance liquid chromatography (HPLC)/electrophoresis.
- •4.Subject must have experienced at least 2 VOCs within the 12 months prior to Screening.
- •A VOC is defined as:
- •a. The occurrence of appropriate symptoms consistent with a painful crisis, acute
- •chest syndrome (ACS), or priapism, and
- •b. Requires a visit to a medical facility and/or healthcare professional, and
- •c. Receipt of either a parenteral or oral opioid or NSAID analgesia.
- •5.If subject is receiving hydroxyurea (HU)/hydroxycarbamide (HC), subject must have been
- •receiving the treatment for at least 6 months prior to Screening and must agree to maintain the same dose and schedule for the duration of the study.
- •6.Subjects must have laboratory values at Screening within the following ranges:
- •Absolute Neutrophil Count =1.0 x 109/L
- •Platelets = 75 x 109/L
- •Hemoglobin (Hgb) = 6.0 g/dL
- •Glomerular filtration rate (GFR) = 45 mL/min/1.73 m2 using the CKD-EPI formula
- •Direct (conjugated) bilirubin = 2.0 x ULN
- •Alanine transaminase (ALT) = 3.0 x ULN
- •International Normalized Ratio (INR) = 2.0
- •7.Eastern Cooperate Oncology Group (ECOG) performance status = 2.
- •8.Women of child-bearing potential, defined as all women physiologically capable of
- •becoming pregnant, must have a negative serum pregnancy test at Screening and agree to
- •use standard prevention methods for the duration of the study.
排除标准
- •1.Subject is receiving concomitant treatment with voxelotor, crizanlizumab, or L-glutamine.
- •2.Subject has any history of stem cell transplant is planning to begin or has received in the
- •past 30 days.
- •3.Subject experiences an acute VOC, requiring a visit to a medical facility and/or healthcare
- •professional, ending within 7 days prior to Day 1 dosing.
- •4.Subject has received any blood products within 30 days of Day 1 dosing.
- •5.Subject has uncontrolled liver disease or renal impairment, ulcerative colitis, Crohn’s
- •disease, or other chronic GI disorder.
- •6.Subject has received active treatment in another investigational trial within 30 days or 5
- •half-lives of the last dose of the investigational agent, whichever is greater, prior to
- •7.Subject has received penicillin prophylaxis or antibiotics for treatment of infection within
- •30 days or 5 half-lives of the treatment, whichever is greater, prior to Screening.
- •8.Subject has a significant medical condition that required hospitalization (other than for a
- •VOC) within 2 months prior to Screening.
- •9.Subject is planning on undergoing an exchange transfusion during the duration of the study
- •or has completed one within 4 weeks prior to Day 1 dosing.
- •10.Subject has a hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any components of rifaximin ER and DER.
- •11.Subject has used therapeutic anticoagulation (prophylactic doses are permitted) or
- •antiplatelet therapy (other than aspirin or NSAIDs) within 10 days prior to Day 1 dosing.
- •12.Subject is pregnant or a nursing woman.
- •13.Subject has a history of illicit drug use or abuse, either documented or in the opinion of the Investigator.
- •14.Subject is using any medication that is known to inhibit or induce CYP3A4, P-gp, or
- •OATP1B1/B3 (See Appendix 3) within 30 days or 5 half-lives, whichever is longer, prior
- •to Day 1 dosing, or in the opinion of the Investigator, may affect the evaluation of the study
- •product or place the subject at
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