CMX001 in Post-transplant Patients With BK Virus Viruria
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|ClinicalTrials.gov Identifier: NCT00793598|
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : July 16, 2021
Last Update Posted : August 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Viruria||Drug: Placebo Drug: Brincidofovir||Phase 1 Phase 2|
This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus infection.
Subjects received blinded study medication for a total of 5 doses in 1 of the following regimens:
- 10 mg BCV administered twice weekly (BIW) on Days 0, 3, 7, 10, 14.
- 20 mg BCV administered once weekly (QW) on Days 0, 7, and 14 and placebo administered on Days 3 or 10.
- Placebo administered BIW on Days 0, 3, 7, 10 ,14.
- 40 mg BCV administered QW on Days 0, 7, 14, 21, and 28.
- Placebo administered QW on Days 0, 7, 14, 21, and 28.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||November 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Under Amendments 1 and 2, subjects received 1 of 2 dose regimens of brincidofovir, as follows:
Under Amendment 3, subjects received 40 mg BCV QW for a total of 5 doses on Days 0, 7, 14, 21, and 28.
Placebo Comparator: Placebo
Under Amendments 1 and 2, subjects received placebo twice weekly (BIW) for a total of 5 doses on Days 0, 3, 7, 10, and 14.
Under Amendment 3, subjects received placebo once weekly (QW) for a total of 5 doses on Days 0, 7, 14, 21, and 28.
- Number of Adverse Events in Post-Transplant Patients With BK Virus Viruria [ Time Frame: 35 days (Day 0 to Day 35) ]The primary objective of this study was to determine the safety and tolerability of brincidofovir (BCV) in post-transplant patients with BK virus viruria. Safety measures included adverse events, clinical laboratory values, vital signs, and renal and gastrointestinal function.
- Percentage of Patients Who Achieved BK Viruria Resolution [ Time Frame: 28 days ]The percentage of subjects who cleared the virus was calculated. Concentrations below the lower limit of quantification were indicated as below the limit of quantitation and were considered "cleared".
- Number of Patients Who Achieved a Clinically Significant Decrease in BK Viruria [ Time Frame: 28 days ]A 2-log drop in viruria or viremia or clearance of virus was considered significant. Percentages of subjects with a 2-log drop in viral load were calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793598
|United States, California|
|California Pacific Medical Center|
|San Francisco, California, United States, 94115|
|University of California, San Francisco|
|San Francisco, California, United States, 94143-0780|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Louisiana|
|Tulane Center for Abdominal Transplant|
|New Orleans, Louisiana, United States, 70112|
|United States, Maryland|
|Johns Hopkins Medical Institutions|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Mt. Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, North Carolina|
|UNC Kidney Center|
|Chapel Hill, North Carolina, United States, 27599|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15260|
|United States, Vermont|
|University of Vermont|
|Burlington, Vermont, United States, 05405|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 19024|