NCT00386412

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

3.8 years

First QC Date

October 9, 2006

Last Update Submit

September 17, 2009

Conditions

Cytomegalovirus Infection

Keywords

Cytomegalovirus infection

Outcome Measures

Primary Outcomes (1)

  • To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.

    1 year

Secondary Outcomes (1)

  • To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.

    1 year

Interventions

ValganciclovirDRUG

900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital Clínico y Provincial de Barcelona

Barcelona, Barcelona, Spain

Location

Hospital Universitario "Germans Trias i Pujol"

Barcelona, Barcelona, Spain

Location

Hospital Universitario de la Princesa

Madrid, Madrid, Spain

Location

Hospital Universitario Ramón y Cajal, Madrid

Madrid, Madrid, Spain

Location

Hospital Universitario Morales Meseguer, Murcia

Murcia, Murcia, Spain

Location

Hospital general de Jerez de la Frontera

Jerez de la Frontera, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

Related Publications (12)

  • Ljungman P, Reusser P, de la Camara R, Einsele H, Engelhard D, Ribaud P, Ward K; European Group for Blood and Marrow Transplantation. Management of CMV infections: recommendations from the infectious diseases working party of the EBMT. Bone Marrow Transplant. 2004 Jun;33(11):1075-81. doi: 10.1038/sj.bmt.1704505. No abstract available.

    PMID: 15077131BACKGROUND

  • Ljungman P, de La Camara R, Milpied N, Volin L, Russell CA, Crisp A, Webster A; Valacyclovir International Bone Marrow Transplant Study Group. Randomized study of valacyclovir as prophylaxis against cytomegalovirus reactivation in recipients of allogeneic bone marrow transplants. Blood. 2002 Apr 15;99(8):3050-6. doi: 10.1182/blood.v99.8.3050.

    PMID: 11929799BACKGROUND

  • Reusser P, Einsele H, Lee J, Volin L, Rovira M, Engelhard D, Finke J, Cordonnier C, Link H, Ljungman P; Infectious Diseases Working Party of the European Group for Blood and Marrow Transplantation. Randomized multicenter trial of foscarnet versus ganciclovir for preemptive therapy of cytomegalovirus infection after allogeneic stem cell transplantation. Blood. 2002 Feb 15;99(4):1159-64. doi: 10.1182/blood.v99.4.1159.

    PMID: 11830461BACKGROUND

  • Razonable RR, Paya CV. Valganciclovir for the prevention and treatment of cytomegalovirus disease in immunocompromised hosts. Expert Rev Anti Infect Ther. 2004 Feb;2(1):27-41. doi: 10.1586/14787210.2.1.27.

    PMID: 15482169BACKGROUND

  • Cvetkovic RS, Wellington K. Valganciclovir: a review of its use in the management of CMV infection and disease in immunocompromised patients. Drugs. 2005;65(6):859-78. doi: 10.2165/00003495-200565060-00012.

    PMID: 15819597BACKGROUND

  • Paya C, Humar A, Dominguez E, Washburn K, Blumberg E, Alexander B, Freeman R, Heaton N, Pescovitz MD; Valganciclovir Solid Organ Transplant Study Group. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2004 Apr;4(4):611-20. doi: 10.1111/j.1600-6143.2004.00382.x.

    PMID: 15023154BACKGROUND

  • Clark BS, Chang IF, Karpen SJ, Herrera L, Scott JD, Bristow LJ, Quiros-Tejeira RE, Goss JA. Valganciclovir for the prophylaxis of cytomegalovirus disease in pediatric liver transplant recipients. Transplantation. 2004 May 15;77(9):1480. doi: 10.1097/01.tp.0000123081.81022.33. No abstract available.

    PMID: 15167619BACKGROUND

  • Ciancio G, Burke GW, Mattiazzi A, Leibovici Z, Dowdy L, Roth D, Kupin W, Rosen A, Jorge D, Cirocco RE, Miller J. Cytomegalovirus prophylaxis with valganciclovir in kidney, pancreas-kidney, and pancreas transplantation. Clin Transplant. 2004 Aug;18(4):402-6. doi: 10.1111/j.1399-0012.2004.00180.x.

    PMID: 15233817BACKGROUND

  • 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.

    BACKGROUND

  • Ljungman P, Griffiths P, Paya C. Definitions of cytomegalovirus infection and disease in transplant recipients. Clin Infect Dis. 2002 Apr 15;34(8):1094-7. doi: 10.1086/339329. Epub 2002 Mar 11.

    PMID: 11914998BACKGROUND

  • Burri M, Wiltshire H, Kahlert C, Wouters G, Rudin C. Oral valganciclovir in children: single dose pharmacokinetics in a six-year-old girl. Pediatr Infect Dis J. 2004 Mar;23(3):263-6. doi: 10.1097/01.inf.0000116760.16582.a9.

    PMID: 15014306BACKGROUND

  • Nichols WG, Corey L, Gooley T, Drew WL, Miner R, Huang M, Davis C, Boeckh M. Rising pp65 antigenemia during preemptive anticytomegalovirus therapy after allogeneic hematopoietic stem cell transplantation: risk factors, correlation with DNA load, and outcomes. Blood. 2001 Feb 15;97(4):867-74. doi: 10.1182/blood.v97.4.867.

    PMID: 11159510BACKGROUND

Related Links

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

GanciclovirAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • de la Cámara Rafael, Dr

    Hospital Universitario La Princesa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 9, 2006

First Posted

October 11, 2006

Study Start

November 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

ES(8)