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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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

Detailed description

Clinical trial with a drug in new conditions of use

Conditions

• Cytomegalovirus Infection

Interventions

Type	Name	Description
DRUG	Valganciclovir	900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2006-10-11
• Last updated: 2009-09-18

Locations

8 sites across 1 country: Spain