VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients

Cytomegalovirus Infections Clinical Trial

Official title:

A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431353
• Other study ID #: MV17973
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2007
• Last updated: November 1, 2016
• Start date: April 2004
• Est. completion date: August 2008

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Infections

Intervention

Drug:
• Ganciclovir
5mg/kg iv bid for 21 days
• valganciclovir [Valcyte]
900mg po bid for 21 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Brazil,  Canada,  Croatia,  Estonia,  India,  Ireland,  Italy,  Latvia,  Mexico,  New Zealand,  Norway,  Poland,  Serbia,  Spain,  Switzerland,  Turkey,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment success (CMV viremia BLQ)		Day 21	No
Secondary	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.		Throughout study	No
Secondary	AEs, laboratory parameters, appearance of ganciclovir resistance.		Throughout study	No