EUCTR2017-003284-35-BE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. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects
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;
- •o 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 protocol-specific procedures being performed;
- •? Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months after end of study or early termination. Contraception should be in place at least 3 months prior to study participation. Women must be 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) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. 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 an infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male participants should use condoms and should not donate sperm as long as contraception is required.
- •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 study:
- •? 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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