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Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Primary Purpose

Adenovirus

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Brincidofovir
Sponsored by
Chimerix
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Adenovirus focused on measuring Adenovirus Brincidofovir

Eligibility Criteria

2 Months - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Confirmed serious AdV infection based on clinical symptoms and laboratory testing showing AdV in the blood or other bodily fluids
  • Able to swallow medication, either tablet or liquid

Exclusion Criteria:

  • Previous dosing with Brincidofovir
  • If female, not pregnant or trying to become pregnant

Sites / Locations

  • University of Arkansas Medical Center
  • Children's Hospital LA
  • UCLA Medical Center
  • Children's Hospital of Orange County
  • Pediatric Stem Cell Transplantation Stanford University
  • Stanford University
  • UC San Diego Moores Cancer center
  • University of California San Francisco Benioff Children's Hospital
  • Children's Hospital Colorado
  • Children's National Medical Center
  • University of Florida
  • All Childrens Research Institute
  • All Children's Research Institute
  • Emory University-AFLAC Cancer and Blood Disorder Clinic
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • University of Chicago
  • Children's Mercy Hospital
  • University of Louisville-Kosair Childrens Hospital
  • Children's Hospital New Orleans
  • Brigham & Woman's Hospital/Boston
  • Michigan State/Spectrum Health
  • Washington University
  • University of Nebraska
  • Hackensack University MC
  • The Children's Hospital at Montefiore
  • Weill Conrell Medical Center
  • Morgan Stanley Children's Hospital
  • Memorial Sloan Kettering
  • New York Medical College-Maria Fareri Childrens hospital
  • New York Medical College, Maria Fareri Children's Hospital
  • Levine Children's Hospital
  • Duke University Medical System
  • Cincinnatti Children's Hospital
  • Cleveland Clinic
  • Nationwide Children's Hospital
  • The Childrens hospital of Philadelphia
  • Methodist University Hospital-BMT program west clinic
  • St. Jude Research Hospital
  • UT Southwestern Medical Center
  • Cook Children's Health Care System
  • Baylor College of Medicine-Infectious Disease
  • University of Texas, MD Anderson Cancer Center
  • Methodist Children's Hospital of South Texas
  • University of Washington/ Seattle Children's Hospital
  • Fred Hutchinson Cancer Research Center
  • Medical College of Wisconsin

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 2015
Last Updated
March 10, 2022
Sponsor
Chimerix
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1. Study Identification

Unique Protocol Identification Number
NCT02596997
Brief Title
Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease
Official Title
An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease
Study Type
Expanded Access

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chimerix

4. Oversight

5. Study Description

Brief Summary
Provide patients with serious AdV infection or disease access to treatment with BCV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenovirus
Keywords
Adenovirus Brincidofovir

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Brincidofovir
Other Intervention Name(s)
BCV CMX001
Intervention Description
Up to 100mg Brincidofovir twice weekly, not to exceed a total dose of 200mg each week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Eligibility Criteria
Inclusion Criteria: Confirmed serious AdV infection based on clinical symptoms and laboratory testing showing AdV in the blood or other bodily fluids Able to swallow medication, either tablet or liquid Exclusion Criteria: Previous dosing with Brincidofovir If female, not pregnant or trying to become pregnant
Facility Information:
Facility Name
University of Arkansas Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Children's Hospital LA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pediatric Stem Cell Transplantation Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UC San Diego Moores Cancer center
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California San Francisco Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
All Childrens Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
All Children's Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Emory University-AFLAC Cancer and Blood Disorder Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64108
Country
United States
Facility Name
University of Louisville-Kosair Childrens Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
Children's Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Brigham & Woman's Hospital/Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Michigan State/Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5400
Country
United States
Facility Name
Hackensack University MC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
The Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Weill Conrell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Morgan Stanley Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
New York Medical College-Maria Fareri Childrens hospital
City
New York
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
New York Medical College, Maria Fareri Children's Hospital
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnatti Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Childrens hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Methodist University Hospital-BMT program west clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
St. Jude Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Cook Children's Health Care System
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine-Infectious Disease
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Washington/ Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Medical College of Wisconsin
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

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