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Trial record 1 of 1 for:    "expanded access protocol to provide brincidofovir"
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02596997
Recruitment Status : Available
First Posted : November 4, 2015
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months and older   (Child, Adult, Senior)
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

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


Contacts
Contact: Garrett Nichols, MD 919-287-6006 gnichols@chimerix.com

  Show 45 Study Locations
Sponsors and Collaborators
Chimerix
More Information

Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT02596997     History of Changes
Other Study ID Numbers: CMX001-351
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017

Keywords provided by Chimerix:
Adenovirus Brincidofovir

Additional relevant MeSH terms:
Adenoviridae Infections
DNA Virus Infections
Virus Diseases