EUCTR2017-003284-35-HU进行中（未招募）1 期
A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - A Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ABIVAX
- 入组人数
- 30
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
- •A subject will be eligible for inclusion in this study only if ALL of the
- •following criteria apply:
- •? Subjects previously enrolled in the ABX464-101 clinical study who have
- •completed the initial 2-month treatment phase;
- •? Subjects able and willing to comply with study visits and procedures;
- •? Subjects with hematological and biochemical laboratory parameters as
- •follows at the D56 visit of the ABX464-101 study:
- •o Hemoglobin > 9.0 g dL-1;
- •o Absolute neutrophil count = 750 mm-3;
- •o Platelets = 100,000 mm-3;
- •o Total serum creatinine = 1.3 x ULN (upper limit of normal);
- •o Creatinine clearance > 50 mL min-1 by the Cockcroft-Gault equation;
- •Total serum bilirubin < 1.5 x ULN;
- •o Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 1.5 x ULN;
- •? Subjects should understand, sign and date the written voluntary
- •informed consent form at the enrolment visit prior to any
- •protocolspecific
- •procedures being performed;
- •? Subjects should be affiliated to a social security regimen (for French
- •sites only);
- •? Females and males receiving the study treatment and their partners
- •must agree to use a highly effective contraceptive method during the
- •study and for 3 months after end of study or early termination.
- •Contraception should be in place at least 3 months prior to study
- •participation. Women must be either postmenopausal (at least 12
- •months of amenorrhea), surgically sterile or if of childbearing potential
- •must use a highly effective contraceptive method. Women of
- •childbearing potential (WOCBP) will enter the study after confirmed
- •menstrual period and a negative pregnancy test. Highly effective
- •methods of contraception include: true abstinence, intrauterine device
- •(IUD), intrauterine hormone-releasing system (IUS), hormonal
- •contraception (estrogen and progestogen or progestogen only)
- •associated with inhibition of ovulation, bilateral tubal occlusion,
- •vasectomized partner. True abstinence is defined when this is in line
- •with the preferred and usual lifestyle of the subject. In each case of
- •delayed menstrual period (over one month between menstruations)
- •confirmation of absence of pregnancy is required.
- •This recommendation also applies to WOCBP with infrequent or irregular
- •menstrual cycle.
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •The following criterion should be checked at the time of screening. If
- •this exclusion criterion applies, the subject will not be included in the
- •? Any condition, which in the opinion of the investigator, could
- •compromise the subject's safety or the adherence to the study protocol.
研究者
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