EUCTR2014-003002-32-GRActive, not recruitingPhase 1
Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI) - PROFILE
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Astellas Pharma Europe Ltd.
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •? Subject is aged at least 18
- •? Confirmed diagnosis or history of IBD for at least 3 months
- •? CDI confirmed positive according to local standard testing for the presence of C. difficile within 48 hr prior to enrolment.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
- •Subject is taking or requiring to be treated with prohibited medications
- •Presence of an ostomy or short bowel syndrome
- •Subject has a current diagnosis of toxic megacolon
- •Subject has previously participated in a CDI vaccine study
- •Subject has hypersensitivity to fidaxomicin or any of its components
Investigators
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