Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Adenovirus Disease
Interventions
DRUG

Brincidofovir

"* Adult subjects: 200mg BCV administered as 50mg tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).~* Pediatric subjects: 4mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg)."

OTHER

Placebo

"Adult subjects: Matching placebo tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).~• Pediatric subjects: Matching liquid placebo taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg)."

Trial Locations (30)

10021

Memorial Sloan Kettering, New York

10595

New York Medical College, Valhalla

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

The Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

27710

Duke University Medical Center, Durham

35233

Children's Hospital of Alabama, Birmingham

37232

Vanderbilt University Medical Center, Nashville

38105

St. Judes Children's Research Hospital, Memphis

44195

Cleveland Clinic, Cleveland

45229

Cincinnati Childrens Hospital, Cincinnati

46202

Indiana University, Indianapolis

55455

Univeristy of Minnesota, Minneapolis

63110

St. Louis Children's Hosptial, St Louis

70118

LSU Health Sciences Center New Orleans Childrens Hospital, New Orleans

75390

UT Southwestern, Dallas

77030

Baylor College of Medicine, Texas Childrens Hospital, Houston

MD Anderson Cancer Center, Houston

78229

Methodist Hospital, San Antonio

80045

The Children's Hospital-Denver, Aurora

84113

Primary Children's Medical of Utah, Salt Lake City

85016

Pheonix Children's Hospital, Phoenix

90033

Childrens hospital of LA, Los Angeles

91010

City of Hope National Medical Center, Duarte

92868

CHOC Children's Hospital, Orange

94143

University of California, San Francisco, San Francisco

94304

Lucile Packard Childrens hopsital at Stanford, Stanford

98109

Seattle Cancer Care Alliance, Seattle

02115

Harvard-Children's Hospital Boston, Boston

07601

Hackensack University Medical Center, Hackensack

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY