VICTOR Study - A Study of Valcyte (Valganciclovir po) Com... | NCT00431353

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

NCT00431353

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

325Actual

Phase

Phase 4

Conditions

Cytomegalovirus Infections

Interventions

Ganciclovir
valganciclovir [Valcyte]

Countries

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

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Feb 2, 2007

First Submission Date that Met QC Criteria

Feb 2, 2007

First Posted Date

Feb 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

325Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: valganciclovir [Valcyte]
2	Experimental		Drug: Ganciclovir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ganciclovir	Drug	5mg/kg iv bid for 21 days	2
valganciclovir [Valcyte]

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of treatment success (CMV viremia BLQ)		Day 21

Secondary Outcomes

Measure	Description	Time Frame
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
AEs, laboratory parameters, appearance of ganciclovir resistance.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39807668	Derived	Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
38700045	Derived

Facility	Status	City	State	ZIP	Country	Contacts
		Chermside		4032	Australia

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Term
D000212	Acyclovir
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds