TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00386412
First received: October 9, 2006
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal, Madrid
Madrid, Spain
Hospital Universitario de la Princesa
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
Study First Received: October 9, 2006
Last Updated: September 17, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Cytomegalovirus infection

Additional relevant MeSH terms:
Infection
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014