Study for the treatment of cytomegalovirus infection, in transplanted patients

Phase 1

Conditions: Cytomegalovirus infection in patients treated with hematopoietic allogenic transplant
MedDRA version: 13.1Level: HLTClassification code 10011827Term: Cytomegaloviral infectionsSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-001449-34-ES

Lead Sponsor: FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

-Patients older than 18.
-Patients undergoing any form of allogeneic hematopoietic progenitors transplant.
-Positive CMV serology in patient and/or donor.
-Prospective virologic and immune monitoring and systematic posttransplant .
-First episode of CMV detection in blood by antigemia or PCR before day +100 after transplantation. The level of pp65 antigenemia or PCR-CMV by quantitative PCR used in each participating center is detailed in Annexe II.
-The first anti-CMV treatment should be made as soon as possible to the positive antigenemia or PCR, with a maximum of 72h after obtaining the positive test to determine the start of treatment.
-Signing the informed consent to participate in the study.
-Negative pregnancy test in patients of childbearing age.
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 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

-Patients receiving autologous or syngeneic transplant.
-Patients <50 kg in weight.
-Patients with a history of allergy or hypersensitivity to valganciclovir, ganciclovir or acyclovir. Due to the similarity in chemical structure of valganciclovir, aciclovir and valaciclovir, is likely to occur cross-hypersensitivity reaction between these drugs so Valganciclovir is contraindicated in patients with hypersensitivity to aciclovir and valaciclovir.
-Disease-tested for this virus is detected when the infection or who are in suspicious box evaluation of CMV disease.
-Have submitted 1 episode of CMV infection before the current episode.
-Submit severe liver disease defined by a bilirubin ? 10 mg/dl.
-Have received foscarnet, ganciclovir, cidofovir or other antiviral agent with activity against CMV clear within 30 days prior to the current episode. The use of acyclovir is allowed, as immunoglobulins.
-Less than 500 neutrophils / mm3, despite treatment with G-CSF, at the time of starting treatment. Patients with> 500 PMN / mm3 but <1000 neutrophils / mm3 should start treatment with G-CSF for neutrophil count is always> 1000 / mm3.
-Platelets <25,000 / mm3 despite transfusion.
-Creatinine clearance <10 ml / min or patients on dialysis. These patients should not receive valganciclovir.
-Patients who are pregnant or breastfeeding, if they are women of childbearing age should have a negative pregnancy test (urine or serum) and use effective contraception