TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant - Full Text View

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:

MedlinePlus related topics: Cytomegalovirus Infections

Drug Information available for: Valganciclovir hydrochloride

U.S. FDA Resources

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:

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

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:

Spanish association of Haematology This link exits the ClinicalTrials.gov site

Publications:

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. No abstract available.

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.

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.

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. Review.

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. Review.

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.

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. No abstract available.

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.

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.

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. Epub 2002 Mar 11. Review.

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.

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.

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:

Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir

Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013