EUCTR2016-004905-15-ES进行中（未招募）1 期
Phase 2 Randomized, Multicenter, Double-blinded Safety and Efficacy Study to Evaluate Oral Fexinidazole Dosing Regimens for the Treatment of Adult Patients with Chronic Indeterminate Chagas Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
入选标准
- •1. Confirmed diagnosis of T. cruzi infection by:
- •Serial qualitative PCR (three samples collected over a single day, at least one of which must be positive),
- •Conventional serology (a minimum of two positive tests must be positive [Conventional ELISA, Recombinant Elisa and/or IIF)
- •2. Women in reproductive age must have a negative serum pregnancy test at screening, must not be breastfeeding, must consistently use a highly effective contraceptive method until end of treatment and estimated FEXI, M1 and M2 clearance (total of 21 days). After this, contraception is no longer required.
- •3. Normal ECG (Heart rate: 50-100bpm; PR =200 msec, QRS <120 msec, and QTc =350msec and =450 msec interval durations) at screening
- •4. 24 hour Holter-monitoring with no clinically relevant arrythmias (defined as Ventricular Tachycardia (defined as >3 ventricular beats with >100bpm); Sustained Accelerated Idio-Ventricular rhythm (defined as >30 seconds duration and HR: 50bpm 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 45
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Signs and/or symptoms of chronic cardiac and/or digestive form of CD (as per Study Manual of Operations).
- •History of cardiomyopathy, heart failure, or ventricular arrhythmia.
- •History of digestive surgery or mega syndromes.
- •Personal or family history of mental disability, suicidal tendencies or any other neuropsychiatric disorders, including previous treatment for anxiety or depression.
- •Hospital Anxiety and Depression Scale (HADS – Appendix 1) self-assessment score >11 in each of the sub-scales. (Note: If HADS score >11, retesting would be allowed before after a minimum period of 15 days and referral to counseling/evaluation.)
- •Any other acute or chronic health conditions that, in the opinion of the PI, may interfere with the efficacy and/or safety evaluation of the trial drug (such as acute infections, history of HIV infection, diabetes, uncontrolled systolic/diastolic blood pressure, liver, and renal diseases requiring medical treatment).
- •Laboratory test values considered clinically significant or out of the allowable range at selection period as follows:
- •oTotal WBC must be within the normal range, with an acceptable margin of +/- 5% (3,800 – 10,500 / mm3).
- •oPlatelets must be within the normal range up to 550,000/mm3
- •oTotal bilirubin must be within the normal range
- •oTransaminases (ALT and AST) must be within the normal range, with an acceptable margin of 25% above the upper limit of normality (ULN), < 1.25 x ULN.
- •oCreatinine must be within an acceptable margin of 10% above the ULN, <1.10 x ULN.
- •oAlkaline phosphatase must be within the normal range up to Grade 1 CTCAE (<,2.5 x ULN)
- •oGGT must be within the normal range up to 2x ULN.
- •oFasting glucose (minimum of 8 hours from latest meal) must be within the normal range
- •oElectrolytes (Ca, Mg, K) must be within the normal range
- •oHepatitis screen must be negative for acute and/or chronic infection (Hepatitis A antibody, IgM; Hepatitis B surface Ag, Hepatitis B core antibody, IgM/IgG, anti-HBs; Hepatitis C antibody)
- •If the results of the blood tests (hematology and biochemistry) are out of the ranges defined above, but within the limits of CTCAE (version 4.03) Grade 1, and this laboratory finding is considered as non-clinically significant, a new sample can be collected for a retest. Only one retest will be allowed within the screening period.
- •If the result of the retest is within the margins defined above, the Investigator will review the parameter(s) together with all other medical information available (medical history, clinical examinations, vital signs, etc.) and upon his/her medical judgement will decide if the patient is eligible or not for trial randomization.
- •Any condition that prevents the patient from taking oral medication.
- •Patients with any contra-indication (known hypersensitivity) to any nitroimidazoles, e.g. metronidazole
- •Patients with history of allergy (serious or not), allergic skin rash, asthma, intolerance, sensitivity or photosensitivity to any drug
- •Any concomitant use of allopurinol, antimicrobial, or anti-parasitic agents and/or of herbal medicines, food supplements and ene
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