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TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

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ClinicalTrials.gov Identifier: NCT00386412
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:

Study Description
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


Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Drug: Valganciclovir Phase 2

Detailed Description:
Clinical trial with a drug in new conditions of use

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005
Primary Completion Date : September 2009
Study Completion Date : September 2009


Arms and Interventions

Intervention Details:
    Drug: Valganciclovir
    900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386412


Locations
Spain
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
Investigators
Study Chair: de la Cámara Rafael, Dr Hospital Universitario La Princesa
More Information

Additional Information:
Publications:
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
ClinicalTrials.gov Identifier: NCT00386412     History of Changes
Other Study ID Numbers: 2005-002813-19.
TAMOVALCIR in alogenic
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by PETHEMA Foundation:
Cytomegalovirus infection

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents