LBCTR2022095104已完成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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •A subject will be eligible for inclusion in this study if he/she meets all the following criteria:
- •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 (Section 2.2.3) , 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 as follows:
- •a. Absolute Neutrophil Count (ANC) =1.0 x 109/L
- •b. Platelets = 75 x 109/L
- •c. Hemoglobin (Hgb) = 6.0 g/dL
- •d. Glomerular filtration rate (GFR) = 45 mL/min/1.73 m2 using the CKD-EPI formula
- •e. Total bilirubin = 15 mg/dL
- •f. Alanine transaminase (ALT) = 3.0 x ULN
- •g. 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
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •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 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 prior to 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 Screening.
- •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 is pregnant or a nursing woman.
- •12. Subject has a history of illicit drug use or abuse, either documented or in the opinion of the Investigator.
- •13. Subject is using any medication that is known to inhibit or induce CYP3A4, P-gp and OATP1B1/B3 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 undue risk.
- •14. Subject has had any prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach, or small/large intestine (with the exception of appendectomy, cholecystectomy, and fundoplication).
- •15. Subject has had a colonoscopy or sigmoidoscopy within 30 days prior to Day 1 or plans to undergo such a procedure during the duration of the study.
- •16. Subject has used bowel prep, laxative, or enema within 30 days prior to Day 1.
- •17. Subject has a bleeding disorder including, but not limited to, acquired or congenital platelet function defects, disseminated intravascular coagulation (DIC), bleeding factor deficiencies, hemophilia, idiopathic thrombocytopenia purpura (ITP), or von Willebrand’s disease.
- •18. Subject is planning to undergo a major surgical procedure during the duration of the study.
- •19. Subject has a positive test for human immunodeficiency virus (HIV)1 or HIV2.
- •20. Subject has an active Hepatitis B infection (HBsAg positive). Prior infection that is not active (i.e., HBsAg negative, HBcAb positive, and HBsAb positive) is permitted.
- •21. Subject has a positive test for Hepatitis C (HCV RNA). Prior infection with spontaneous resolution or sustained resolution for = 24 weeks after cessation of antivirals is permitted.
- •22. Subject has an active COVID-19 infection or complication(s) related to COVID-19 infection that are unresolved or, in the opinion of the Investigator, may affect evaluation of the study drug or place the subject at undue risk.
- •23. Subjects has received a vaccine (including COVID-19 vaccine) within 2
研究者
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