VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Infections
Intervention: valganciclovir [Valcyte] (Drug); Ganciclovir (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Summary
This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with
intravenous ganciclovir for the treatment of CMV disease in solid organ transplant
recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or
2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the
target sample size is 100-500 individuals.
Clinical Details
Official title: A Randomized, Open-Label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Incidence of treatment success (CMV viremia BLQ)
Secondary outcome: Time to eradication of CMV viremia, percentage of patients with resolution of symptoms, percentage of patients with eradication of CMV viremia, time to CMV viremia recurrence, effect on HHV-6, HHV-7 and EBV viremia.AEs, laboratory parameters, appearance of ganciclovir resistance.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adult patients >=18 years of age;
- recipients of solid organ(s) transplant;
- virologic and clinical evidence of CMV disease after transplantation;
- patients of childbearing potential must be prepared to use effective contraception
throughout, and for 90 days after the end of the study.
Exclusion Criteria:
- life-threatening CMV disease according to the investigator's judgment;
- pregnant or lactating women.
Locations and Contacts
DARLINGHURST 2010, Australia
WOOLLOONGABBA 4102, Australia
SYDNEY 2145, Australia
CHERMSIDE 4032, Australia
WIEN 1090, Austria
BRUXELLES 1070, Belgium
PORTO ALEGRE 90240-520, Brazil
SAO PAULO 01323-900, Brazil
SAO PAULO 04038-002, Brazil
SAO PAULO 05403-900, Brazil
SAO PAULO 05651-901, Brazil
CAMPINAS 13083-970, Brazil
ZAGREB 10000, Croatia
TALLINN 10617, Estonia
TARTU 51014, Estonia
NEW DELHI 110 044, India
VELLORE 632 004, India
CHENNAI 600 004, India
LUCKNOW 226 014, India
PADOVA 35128, Italy
COPPITO 67100, Italy
RIGA 1002, Latvia
AGUASCALIENTES 20230, Mexico
AUCKLAND, New Zealand
OSLO, Norway
ZABRZE 41-800, Poland
WARSZAWA 02-006, Poland
GDANSK 80-211, Poland
WROCLAW 50-417, Poland
BYDGOSZCZ 85-094, Poland
POZNAN 60-479, Poland
BELGRADE 11000, Serbia
BILBAO, Spain
MADRID, Spain
LA LAGUNA, Spain
ALICANTE 03010, Spain
BASEL 4031, Switzerland
ANTALYA 07000, Turkey
IZMIR 35100, Turkey
ISTANBUL 34126, Turkey
ISTANBUL 34662, Turkey
OXFORD OX3 7LJ, United Kingdom
LIVERPOOL L7 8XP, United Kingdom
MARACAIBO 4001, Venezuela
CARACAS 1040, Venezuela
EDMONTON, Alberta T6G 2B7, Canada
TORONTO, Ontario M5G 1L7, Canada
Additional Information
Starting date: April 2004
Ending date: May 2007
Last updated: June 17, 2008
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