EUCTR2018-003300-39-ES
Active, not recruiting
Phase 1
Clinical trial of efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis in lung transplant recipients. - CYTOCOR
Fundación para la Investigación Biomédica de Córdoba0 sites150 target enrollmentOctober 25, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación para la Investigación Biomédica de Córdoba
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with cytomegalovirus positive serology who underwent lung transplantation.
- •Subjects of 18 years of age or older.
- •Expected valgancilovir prophylactic treatment of 6 months after transplantation.
- •Patients who have signed the informed consent form.
- •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 127
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 23
Exclusion Criteria
- •HIV infected subjects.
- •Pregnant and/or lactating women.
- •Intolerance to Valganciclovir/Ganciclovir.
- •Subjects unable to comply with the protocolo follow\-up visits.
- •Subjects who underwent multivisceral transplant.
Outcomes
Primary Outcomes
Not specified
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