Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection

Completed · Phase 3

Conditions studied: Adenovirus Infection

In brief

This was a Phase 3 open-label, non-randomized, multicenter study of oral brincidofovir (BCV) administered twice weekly for the treatment of adenovirus (AdV) infection detected during asymptomatic AdV viremia or during symptomatic AdV infection.

Key facts

Study ID

NCT02087306

Run by

Jazz Pharmaceuticals

People needed

201

Starts

2014-03-01

Expected to finish

2016-08-01

Last updated by the study team

2021-08-13

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who met any of the following criteria (as applicable) were not eligible to participate in this study:
• If a female of reproductive potential, the subject was pregnant, planning to become pregnant during the study or within 6 months after their anticipated last BCV dose, or was nursing a child.
• Had hypersensitivity (not including renal dysfunction or eye disorder) to cidofovir (CDV) or to BCV or its formulation excipients.
• Had received treatment with another investigational drug within 14 days prior to Day 1 unless prior approval was received from the Chimerix medical monitor (or designee).
• Were participating in another interventional clinical trial unless prior approval was received from the Chimerix medical monitor (or designee).
• Had previously received an anti-AdV vaccine or a cell-based anti-AdV therapy.
• Were receiving intravenous (IV) CDV, leflunomide, vidarabine, systemic ribavirin, or another investigational anti-AdV drug at Day 1. [Note: Subjects who were receiving treatment with IV CDV prior to enrollment had to discontinue IV CDV and wait until a minimum of 48 hours had elapsed from last IV CDV administration before initiating BCV therapy. All other drugs had to be discontinued prior to Day 1.]
• Were receiving digoxin or ketoconazole (other than topical formulations) at Day 1 or were anticipated to need treatment with either drug during the treatment phase of the study.
• Were infected with HIV, hepatitis B virus (HBV), and/or hepatitis C virus (HCV), had evidence of active viral replication within 6 months prior to screening, as demonstrated by detectable HIV or HCV RNA, or had detectable HBV DNA in blood, plasma or serum.
• Had end-stage renal disease, i.e., an estimated glomerular filtration rate <15 mL/min, unless receiving renal replacement therapy.
• Had a serum alanine aminotransferase or aspartate aminotransferase concentration >5 x the upper limit of normal (ULN), or a serum total bilirubin concentration >2 x the ULN and a serum direct (conjugated) bilirubin concentration >1.5 x the ULN, as reported by the central safety laboratory, unless, in the judgment of the investigator, the abnormality(ies) was/were related to the subject's AdV infection/disease.
• Had ongoing Grade 3 or higher diarrhea, unless, in the judgment of the investigator, the diarrhea was related to the subject's underlying AdV infection/disease.
• Had Stage 3 or higher graft versus host disease (GVHD) of the intestine (GI-GVHD or any other GI disease that would have, in the judgment of the investigator, precluded the subject from taking or absorbing oral medication (e.g., clinically active Crohn's disease, ischemic colitis, moderate or severe ulcerative colitis, small bowel resection, ileus, or any condition expected to require abdominal surgery during the course of study participation).
• Had any other condition, including abnormal laboratory values, that would have, in the judgment of the investigator, put the subject at increased risk by participating in the study, or would have interfered with the conduct or planned analyses of the study.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Stanford Children's Hospital — Palo Alto, California, United States
• Stanford University — Stanford, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National Health System — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta, Aflac Cancer and Blood Center — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Children's Hospital — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Brigham and Woman's Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College/ New York Presbyterian Hospital — New York, New York, United States
• Montifore Medical Center — The Bronx, New York, United States
• Levine Children's Hospital — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• St. Jude Children's Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.