EUCTR2015-002109-12-LV进行中（未招募）1 期
An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •1. Evidence of a personally signed and dated informed consent document
- •2. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and is deemed an appropriate candidate for participation in this long-term extension study
- •3. Eligible female patients must be:
- •a. non-pregnant, evidenced by a negative urine dipstick pregnancy test at Week 12 of study APD334-003
- •b. non-lactating
- •c. sexually abstinent (if this is the preferred and usual lifestyle of the individual. Periodic abstinence [calendar, symptothermal, post-ovulation methods], withdrawal [coitus interruptus], and lactational amenorrhoea method are not acceptable methods of contraception), surgically sterile, postmenopausal, or agree to continue to use an accepted method of birth control during and for at least 30 days after last study medication administration. Acceptable methods of birth control are:
- •- hormonal contraceptives (patients should be consistently taking the hormonal contraceptive for at least 3 months [90 days] prior to screening);
- •- double barrier method (condom and occlusive cap [diaphragm or cervical cap] with spermicide);
- •- an intrauterine device;
- •- surgical sterility for at least 6 months prior to screening for tubal ligation performed laparoscopically, hysterectomy and/or bilateral oophorectomy; and/or postmenopausal (defined as at least 2 years without menses).
- •Contraceptive measures such as Plan B (used after unprotected sex) are not acceptable methods of contraception for this study.
- •4. Eligible male patients must:
- •- Agree to use the double-barrier method (condom and occlusive cap [diaphragm or cervical cap] with spermicide) when sexually active with a female partner who is pregnant, breastfeeding, or not using an acceptable method of birth control, during the study and for 30 days after last study medication administration
- •5. Eligible male and female patients must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for 30 days after the last dose of study drug
- •6. Fulfillment of all eligibility criteria for APD334-003 and completion the study as planned
- •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 216
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. Patients who were withdrawn from study drug treatment due to any AE or SAE, or patients who did not complete the APD334-003 study
- •2. Female patients who wish to become pregnant
- •3. Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
研究者
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