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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT00386412
Eligibility Criteria:
Inclusion Criteria:
* Patients \> 18 years old
* Any patients with allogenic TPH
* Following in post-TPH with antigenemia or PCR-CMV
* CMV in blood test detected by antigenemia or PCR before the day 180 post-TPH
* The beginning of treatment must be Duch early as possible. Maximum in the 72 hours from the antigenemia or PCR-CMV detection
* Be the first or second time of a CMV infection
* Sign the informed consent
* Pregnancy negative test in fertile age patients
Exclusion Criteria:
* Patients received auto or syngenic TPH
* Patients \<50 kg weight
* Known allergy or hypersensibility patients to valganciclovir, ganciclovir or aciclovir
* Digestive intolerant: nauseous, vomit and or diarrhea that could difficult oral administration of valganciclovir
* Patients that presents CMV infection or that is being evaluated for suspected CMV
* Patients that have presented \>2 CMV infection episode, before the current one
* Severe liver disease defined by bilirubin ≥ 10mg/dL
* Treated with: foscarnet, ganciclovir, cidofovir or another antiviral drug active to CMV, in the previous 30 days at the current episode
* Neutrophils \< 500 /µL at the beginning of valganciclovir treatment. Patients with \>500 PMN/µL and \< 1000/µL must start a G-CSF treatment to get neutrophils value \> 1000/µL
* Platelets \< 25/mm3 even receiving transfusion
* Clearance Creatinine \< 10mL/min or dialysed patients
* Pregnancy or lactant women
* Other contraindication detailed in the "filling card"
* Previous inclusión in this study at the treated group. Is allowed that a patient participate as a control case and after that receive valganciclovir treatment in after CMV episode
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT00386412
Study Brief:
Protocol Section:
NCT00386412