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TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

This study has been completed.
Information provided by:
PETHEMA Foundation Identifier:
First received: October 9, 2006
Last updated: September 17, 2009
Last verified: September 2009

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

Condition Intervention Phase
Cytomegalovirus Infection
Drug: Valganciclovir
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Multicentric, Prospective and Opened Clinical Trial of Advance Valganciclovir Treatment of CMV in Allogenic Hematopoietic Progenitors Transplant

Resource links provided by NLM:

Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment. [ Time Frame: 1 year ]

Estimated Enrollment: 132
Study Start Date: November 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Valganciclovir
    900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks
Detailed Description:
Clinical trial with a drug in new conditions of use

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00386412

Hospital Clínico y Provincial de Barcelona
Barcelona, Spain
Hospital Universitario "Germans Trias i Pujol"
Barcelona, Spain
Hospital general de Jerez de la Frontera
Jerez de la Frontera, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal, Madrid
Madrid, Spain
Hospital Universitario Morales Meseguer, Murcia
Murcia, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Sponsors and Collaborators
PETHEMA Foundation
Study Chair: de la Cámara Rafael, Dr Hospital Universitario La Princesa
  More Information

Additional Information:
Einsele H, Reusser P, Hertenstein B, Bornhäuser M, Kröger N, Kahls P, et al. Pharmakokinetics of Valganciclovir after AlloSCT: A Fixed Oral Dose Can Be Used for Preemptive Therapy in Patients with Normal Body Weight - Even with Intestinal GVHD. Blood 2004;104(11):abstract 2239.

Responsible Party: Pethema, pethema Identifier: NCT00386412     History of Changes
Other Study ID Numbers: 2005-002813-19.
TAMOVALCIR in alogenic
Study First Received: October 9, 2006
Last Updated: September 17, 2009

Keywords provided by PETHEMA Foundation:
Cytomegalovirus infection

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents processed this record on April 28, 2017