Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT01318993
Eligibility Criteria:
Inclusion Criteria:
* Previous participation in a GSK-sponsored study with GSK1605786A
* Written informed consent prior to any study-specific procedures
* Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate
Exclusion Criteria:
* If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant
* Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result
* Fixed symptomatic stenoses or strictures of small bowel or colon
* Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
* Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks
* Evidence of hepatic dysfunction or viral hepatitis
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01318993
Study Brief:
Protocol Section:
NCT01318993