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

Completed · Phase 2 · Has a placebo group

Conditions studied: Adenovirus Disease

In brief

This study was designed to assess the safety and efficacy of preemptive treatment with oral brincidofovir (BCV), as compared to placebo, for the prevention of adenovirus (AdV) disease in recipients of hematopoietic stem cell transplantation (HCT) with asymptomatic AdV viremia.

Key facts

Study ID: NCT01241344
Run by: Jazz Pharmaceuticals
People needed: 52
Starts: 2010-11-01
Expected to finish: 2013-06-01
Last updated by the study team: 2021-07-21

Who can join

Age: 0 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For inclusion into the study, subjects were required to fulfill all of the following criteria:
Were males or female aged ≥3 months to ≤75 years.
Received an allogeneic hematopoietic stem cell transplant (HCT).
Had positive serum adenovirus (AdV) PCR (>100 copies/mL) as measured by the central laboratory (unless the subject developed AdV disease while participating in the prescreening activities and after concurrence from the Chimerix medical monitor or designee).
Was on dialysis during treatment if he/she had an estimated glomerular filtration rate (eGFR) ≤30 mL/minute.
Subject or guardian(s) were willing to comply with the protocol.
Subject or guardian(s) were willing and able to understand the informed consent/assent.
Female subjects of child-bearing potential must have had a negative pregnancy test and must have agreed to use 2 acceptable methods of birth control throughout the study with at least 1 being a barrier method. Sexually active males of procreation potential must have been able and willing to se a reliable and medically approved contraceptive method throughout the study. At least 1 barrier method of contraception must have been used.

You may not qualify if…

Subjects meeting any of the following exclusion criteria were excluded from participation in the study:
Had possible, probable, or definitive AdV disease (unless the subject developed probable or definitive AdV disease while participating in prescreening activities and after concurrence from he Chimerix medical monitor or designee).
Had suspected gut graft versus host disease that was not biopsy-proven (subjects with a biopsy performed were included in the study).
Had an eGFR ≤30 mL/minute and was not currently on dialysis.
Had an alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of normal (ULN), total bilirubin ≥2 x the ULN, or conjugated (direct) bilirubin ≥1.5 x the ULN.
Had a condition that prevented oral dosing of study drug.
Was HIV antibody positive, based upon available medical records.
Had ocular hypotony, uveitis, or retinitis or any other intraocular pathology that would have predisposed the subject to 1 of these conditions.
Had participated in another clinical study of an investigational drug/biologic or was exposed to an investigational drug/biologic within 30 days of enrollment without the prior written approval of the Chimerix medical monitor or designee. For subjects who were participating in any clinical study involving non-investigational drugs and/or biologics, the investigator must have obtained approval from the Chimerix medical monitor or designee prior to enrolling the subject.
Was pregnant or breast-feeding or intended to conceive during the course of the study, including the follow-up period after drug discontinuation.
Had known immunologic hypersensitivity to cidofovir (CDV) or brincidofovir (BCV) drug or any of its excipients.
Had a history of illicit drug use or alcohol abuse within the previous 6 months.
Had any medical condition that, in the opinion of the investigator, might have interfered with the subject's participation in the study, posed an added risk for the subject, or confounded the assessment of the subject (e.g. severe cardiovascular, central nervous system or pulmonary disease).
Received BCV, CDV, ribavirin, or leflunomide within the previous 14 days.
Was receiving or was anticipated to need treatment with digoxin that could not have been withheld for the duration of BCV therapy.
Any exemptions to the protocol inclusion or exclusion criteria, as applicable, for subjects who developed probably or definitive AdV disease while participating in prescreening activities must have been discussed with and approved by the Chimerix medical monitor or designee before the subject was allowed to receive open-label BCV therapy.

Where it is running

Children's Hospital of Alabama — Birmingham, Alabama, United States
Pheonix Children's Hospital — Phoenix, Arizona, United States
City of Hope National Medical Center — Duarte, California, United States
Childrens hospital of LA — Los Angeles, California, United States
CHOC Children's Hospital — Orange, California, United States
University of California, San Francisco — San Francisco, California, United States
Lucile Packard Childrens hopsital at Stanford — Stanford, California, United States
The Children's Hospital-Denver — Aurora, Colorado, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Indiana University — Indianapolis, Indiana, United States
LSU Health Sciences Center New Orleans Childrens Hospital — New Orleans, Louisiana, United States
Harvard-Children's Hospital Boston — Boston, Massachusetts, United States
Univeristy of Minnesota — Minneapolis, Minnesota, United States
St. Louis Children's Hosptial — St Louis, Missouri, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Memorial Sloan Kettering — New York, New York, United States
New York Medical College — Valhalla, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
Cincinnati Childrens Hospital — Cincinnati, Ohio, United States
Cleveland Clinic — Cleveland, Ohio, United States
The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
St. Judes Children's Research Hospital — Memphis, Tennessee, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
UT Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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