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Trial record 1 of 8 for:    brincidofovir adenovirus
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Phase III, Open-labeled, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection (CMX001 Adv)

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: NCT02087306
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Chimerix

Tracking Information
First Submitted Date  ICMJE March 12, 2014
First Posted Date  ICMJE March 14, 2014
Last Update Posted Date November 11, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
To compare the overall mortality at Week 24 of subjects treated with BCV during asymptomatic adenovirus (AdV) viremia or "early" AdV infection to the mortality at Week 24 for subjects treated with BCV during symptomatic or "late" AdV disease [ Time Frame: 24 weeks ]
To compare the overall mortality at Week 24 of subjects treated with BCV during asymptomatic adenovirus (AdV) viremia or "early" AdV infection to the mortality at Week 24 for subjects treated with BCV during symptomatic or "late" AdV disease
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02087306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III, Open-labeled, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection
Official Title  ICMJE A Phase 3, Open-Label, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection (Chimerix Study CMX001-304)
Brief Summary This is a multicenter study of Brincidofovir (CMX001) (BCV) administered twice weekly (BIW) for the treatment of AdV infection detected during asymptomatic AdV viremia or during symptomatic AdV infection. After completing a screening assessment to confirm study eligibility, all enrolled subjects will undergo a treatment period of 12 weeks. Beginning on Day 1, adult (≥ 18 years) and adolescent (13-17 years) subjects weighing > 50 kg will receive BCV 100 mg BIW; children up to 12 years of age will receive weight-based doses of 2 mg/kg BIW, not-to-exceed a total dose of 200 mg/week.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenovirus Infection
Intervention  ICMJE Drug: CMX001
CMX001 administered twice weekly, dose depending on weight.
Other Name: Brincidofovir
Study Arms  ICMJE Experimental: CMX001
Intervention: Drug: CMX001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2016)
201
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
20
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who have undergone hematopoietic cell transplant (HCT), solid organ transplant (SOT)
  • Have a primary or other severe immunodeficiency which predisposes to rapid progression to disseminated AdV disease
  • Must be able to ingest, absorb and tolerate oral medication
  • Willing and able to understand and provide written informed consent. For minors or those incapable of providing written informed consent (i.e., incapacitated), understood, written and informed consent must be provided by a parent or legal guardian or representative.
  • To the best of his or her (or parent/guardian) knowledge, willing and able to participate in all required study activities for the duration of the study.

Exclusion Criteria:

  • Females who are pregnant or currently nursing.
  • Patients with any other condition that would, in the judgment of the investigator, put the patient at increased risk during participation in the study, or interfere with the conduct of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02087306
Other Study ID Numbers  ICMJE CMX001 304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chimerix
Study Sponsor  ICMJE Chimerix
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chimerix
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP