TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

Study Overview
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Brief Summary
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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
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Clinical trial with a drug in new conditions of use

Official Title
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Phase II, Multicentric, Prospective and Opened Clinical Trial of Advance Valganciclovir Treatment of CMV in Allogenic Hematopoietic Progenitors Transplant

Conditions
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Cytomegalovirus Infection

Intervention / Treatment
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* Drug: Valganciclovir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valganciclovir|900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytomegalovirus infection