TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant
- Conditions
- Cytomegalovirus Infection
- Registration Number
- NCT00386412
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
PRINCIPAL ENDPOINT To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.
SECONDARY ENDPOINT To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.
The security will be valued by the % of patients that:
Will have negative CMV Neutropenia \<1000 neutrophils/mm3 or \<500 neutrophils/mm3 in the first 35 days of treatment - follow-up Renal toxicity in the first 35 days of treatment - follow-up (defined by elevated creatinine \>1mg/dL or twice the basal value) CMV illness during the treatment or in the next 2 months Blood Antigenemia / PCR positive in the next 2months of treatment
This dates Hill be compared with a patients control group treated with intravenous valganciclovir
- Detailed Description
Clinical trial with a drug in new conditions of use
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment. 1 year
- Secondary Outcome Measures
Name Time Method To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment. 1 year
Trial Locations
- Locations (8)
Hospital Clínico y Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario "Germans Trias i Pujol"
🇪🇸Barcelona, Spain
Hospital Universitario Ramón y Cajal, Madrid
🇪🇸Madrid, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital general de Jerez de la Frontera
🇪🇸Jerez de la Frontera, Spain
Hospital Universitario Morales Meseguer, Murcia
🇪🇸Murcia, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain