Status:
COMPLETED
TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant
Lead Sponsor:
PETHEMA Foundation
Conditions:
Cytomegalovirus Infection
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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...
Detailed Description
Clinical trial with a drug in new conditions of use
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00386412
Start Date
November 1 2005
End Date
September 1 2009
Last Update
September 18 2009
Active Locations (8)
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1
Hospital Clínico y Provincial de Barcelona
Barcelona, Barcelona, Spain
2
Hospital Universitario "Germans Trias i Pujol"
Barcelona, Barcelona, Spain
3
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
4
Hospital Universitario Ramón y Cajal, Madrid
Madrid, Madrid, Spain