CMX001 in Post-transplant Patients With BK Virus Viruria - Full Text View

Sponsor:	Chimerix
Information provided by:	Chimerix
ClinicalTrials.gov Identifier:	NCT00793598

Purpose

Renal and hematopoetic stem cell patients with BK virus viruria post-transplant will be enrolled and randomized to 5 weeks of dosing with CMX001 or placebo. Safety assessments including clinical laboratory evaluations and vital signs measurements will be performed and blood samples will be collected to measure the amount of study drug in the blood. Viral levels will be measured in the blood and urine.

Condition	Intervention	Phase
Viruria	Drug: Placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of the Safety, Tolerability and Population Pharmacokinetics of CMX001 in Post-Transplant Subjects With BK Virus Viruria

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

U.S. FDA Resources

Further study details as provided by Chimerix:

Primary Outcome Measures:

Safety measures (adverse events, clinical laboratory values, vital signs, renal and gastrointestinal function) [ Time Frame: Multiple time points throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PK parameters [ Time Frame: Multiple times, relative to dosing, throughout the study ] [ Designated as safety issue: Yes ]
BK Viral load (urine and plasma) [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: No ]
Patient drop-out rate [ Time Frame: Through out the course of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 40 mg of CMX001 given on Days 0, 7, 14, 21, and 28	Drug: Placebo Placebo given on Days 0, 7, 14, 21 and 28

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stem cell transplant recipients with urine levels of BKV ≥ 10^4 copies/mL.
Renal transplant patients have either
urine levels of BKV DNA ≥ 10^4 copies/mL without viremia OR
plasma levels of BKV DNA < 10^4 copies/mL (with our without viruria)
Renal transplant patients must be at least 28 days post-transplant, have no evidence of graft reject and be on a stable immunosuppressant regimen.
Stem cell transplant patients must be at least 3 days post documentation of successful engraftment.
Able to swallow tablets.

Exclusion Criteria:

Currently nursing or pregnant females.
Unstable or poorly controlled diabetes.
Patients who received aminoglycosides (IV) or NSAIDS (except as given for cardioprotective treatment) within 7 days prior to enrollment.
Patients who received leflunomide, cidofovir or any other medication for treatment of BK virus within 14 days prior to enrollment.
Stem cell transplant recipients who have received ganciclovir or valganciclovir within 14 days prior to enrollment.
Patients who are HIV positive.
Patients with active HCV or HBV infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793598

Contacts

Contact: Carrie Gibson, MPH

513.619.1852

cgibson@ctifacts.com

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143-0780
Principal Investigator: Stephen J Tomlanovich, MD
California Pacific Medical Center	Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Ram V Peddi, MD
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Michael G Ison, MD, MS
United States, Louisiana
Tulane Center for Abdominal Transplant	Recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: Sander S Florman, MD, FACS
United States, Maryland
Johns Hopkins Medical Institutions	Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Aruna Subramanian, MD
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Carole McIntyre-Ramm 734-647-9830
Principal Investigator: Daniel Kaul, MD
United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Daniel C Brennan, MD
United States, North Carolina
UNC Kidney Center	Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Karin True, MD
Wake Forest University Health Sciences	Recruiting
Winston Salem, North Carolina, United States, 27157
Principal Investigator: Kevin P High, MD
United States, Washington
Fred Hutchinson Cancer Research Center	Recruiting
Seattle, Washington, United States, 19024
Principal Investigator: Michael Boeckh, MD

Sponsors and Collaborators

Chimerix

More Information

No publications provided

Responsible Party:	Chimerix ( Wendy Painter/ Chief Medical Officer )
Study ID Numbers:	CMX001-104
Study First Received:	November 17, 2008
Last Updated:	January 8, 2010
ClinicalTrials.gov Identifier:	NCT00793598 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Chimerix:

CMX001
Kidney transplant
HSCT transplant

BK Virus
Post kidney transplant patients with BK virus viruria > 10^4
Post HSCT transplant patients with BK virus viruria > 10^4

ClinicalTrials.gov processed this record on February 08, 2010