- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386412
TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant
Phase II, Multicentric, Prospective and Opened Clinical Trial of Advance Valganciclovir Treatment of CMV in Allogenic Hematopoietic Progenitors Transplant
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
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Barcelona, Spain
- Hospital Clínico y Provincial de Barcelona
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Barcelona, Spain
- Hospital Universitario "Germans Trias i Pujol"
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Jerez de la Frontera, Spain
- Hospital general de Jerez de la Frontera
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Madrid, Spain
- Hospital Universitario La Paz
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Madrid, Spain
- Hospital Universitario de La Princesa
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Madrid, Spain
- Hospital Universitario Ramón y Cajal, Madrid
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Murcia, Spain
- Hospital Universitario Morales Meseguer, Murcia
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Salamanca, Spain
- Hospital Clínico Universitario de Salamanca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: de la Cámara Rafael, Dr, Hospital Universitario La Princesa
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1086/339329. Epub 2002 Mar 11.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-002813-19.
- TAMOVALCIR in alogenic
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