EUCTR2010-022384-35-GR进行中（未招募）不适用
An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
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. Previous participation in a GSK-sponsored study with GSK1605786A as follows:
- •a. completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI => 100 point decrease) or clinical remission (CDAI < 150) at Week 12 or completion of other GSK-sponsored induction studies, with the exception of Study CCX114643, as designated by the sponsor
- •b. completion of maintenance study CCX114157 at Week 52
- •c. withdrawal from maintenance study CCX114157 due to worsening of Crohn’s disease and requiring a treatment change
- •2. Written informed consent prior to any CCX114644-specific study procedures
- •3. Females of child-bearing potential (FCBP) must be sexually inactive or commit to use of contraceptive methods with a failure rate of < 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for the duration of this study as defined by the following: Contraceptive Methods with a Failure Rate of < 1%
- •Abstinence from penile-vaginal intercourse, when this is the female’s preferred and usual lifestyle
- •Oral contraceptive, either combined or progestogen alone
- •Injectable progestogen
- •Implants of etonogestrel or levonorgestrel
- •Estrogenic vaginal ring
- •Percutaneous contraceptive patches
- •Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label
- •Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. The information on the male sterility can come from the site personnel’s: review of subject’s medical records; medical examination of the subject and/or semen analysis; or interview with the subject on his medical history.
- •Male condom combined with a vaginal spermicide (foam, gel, film,
- •cream, or suppository)
- •Male condom combined with a female diaphragm, either with or
- •without a vaginal spermicide (foam, gel, film, cream, or suppository)
- •These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception. This list does not apply to FCBP with same sex partners, when this is their preferred and usual lifestyle.
- •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 766
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1. If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is
- •planning to become pregnant
- •2. Subjects with known or suspected coeliac disease or a positive screening test for antitissue transglutaminase (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive test result.
- •3. Fixed symptomatic stenoses of small bowel or colon
- •4. Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
- •5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks
- •6. Use of prohibited medications at baseline and throughout the study (Section 5.4.2 of the protocol - Prohibited Medications and Non Drug Therapies)
- •7. Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was
- •possibly related to study treatment and poses an unacceptable risk to the subject.
- •8. Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the Investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.
研究者
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