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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02596997
Expanded Access Status : No longer available
First Posted : November 4, 2015
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
Chimerix

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

Condition or disease Intervention/treatment
Adenovirus Drug: Brincidofovir

Study Design
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Study Type : Expanded Access
Official Title: An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Brincidofovir
    Up to 100mg Brincidofovir twice weekly, not to exceed a total dose of 200mg each week
    Other Name: BCV CMX001
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02596997


Locations
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Sponsors and Collaborators
Chimerix
More Information
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Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT02596997    
Other Study ID Numbers: CMX001-351
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: March 14, 2022
Last Verified: February 2020
Keywords provided by Chimerix:
Adenovirus Brincidofovir
Additional relevant MeSH terms:
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Adenoviridae Infections
Infections
DNA Virus Infections
Virus Diseases
 Brincidofovir
Antiviral Agents
Anti-Infective Agents