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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01249820
Eligibility Criteria:
Inclusion Criteria:
* Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for AML-MDS
* Subject is at least 18 and not older than 65 years of age on the day of the first dosing
* Has no signs or symptoms of invasive fungal disease
* If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant
* Has an ALAT, ALAT, alkaline phosphatase \< 5 times the upper limit of normal and a bilirubin level \< 3 times the upper limit of normal
* Is not known to be hypersensitive to echinocandin antifungal agents
* Is managed with a quadruple central venous catheter (Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International)
* Subject is able and willing to sign the Informed Consent before screening evaluations
Exclusion Criteria:
* Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
* Known of Positive HIV test or hepatitis B or C test in history
* History of QT time prolongation
* History of or current abuse of drugs, alcohol or solvents
* Inability to understand the nature of the trial and the procedures required
* Has not previously participated in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01249820
Study Brief:
Protocol Section:
NCT01249820