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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT01559818
Eligibility Criteria:
Inclusion Criteria:
* Patient was previously enrolled in Study IMM-101-001
* Patient gave consent to make their disease and treatment history for the intervening period between their completion of Study IMM-101-001 and enrollment in this study available to the Sponsor
* Patient gave signed informed consent for participation in the study
Exclusion Criteria:
* Female patient of child-bearing potential who was not, in the opinion of the Investigator, using an approved method of birth control (e.g., physical barrier \[patient and partner\], contraceptive pill or patch, spermicide and barrier, or intrauterine device \[IUD\]).
Those patients that utilised hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above) was discontinued from being used concomitantly with the hormonal contraception.
* Patient of non-child-bearing potential were defined as having 12 month amenorrhoea or were surgically sterile.
* Female patient who was pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment urine pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative.
* Patient was unable or unwilling to comply with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01559818
Study Brief:
Protocol Section:
NCT01559818