A Study of the Safety of Intravenous Brincidofovir for Adenovirus Infection

A Randomized, Controlled, Open-Label, Multiple Ascending Dose Study of Intravenous Brincidofovir in Adult Allogeneic Hematopoietic Cell Transplant Recipients with Adenovirus Viremia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003984-37-ES

Enrollment

Registered

2018-06-21

Start date

2018-07-30

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of adenovirus infections in adult allogeneic hematopoietic cell transplant recipients MedDRA version: 20.1 Level: PT Classification code 10060931 Term: Adenovirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Brincidofovir Product Code: CMX001 Pharmaceutical Form: Solution for injection INN or Proposed INN: Brincidofovir (USAN) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For inclusion in this study, subjects must: 1. Be = 18-years-old (or per local law or regulations on legal age of consent). 2. Have received an allogeneic HCT within the previous 100 days. 3. Have plasma AdV DNA viremia = 1,000 copies/mL (via quantitative polymerase chain reaction assay; local results must be confirmed by the designated central virology laboratory). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Diarrhea meeting the US National Institutes of Health (NIH)/National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (i.e., increase of = 4 stools per day over usual pretransplant stool output) within 7 days prior to Day 1. 2. Acute graft versus host disease (GVHD) meeting the following criteria: : NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea > 1,000 mL/day, or severe abdominal pain with or without ileus) or liver (i.e., bilirubin > 3 mg/dL [SI: > 51 µmol/L]) within 7 days prior to Day 1. : Any NIH Stage 3 or Stage 4 acute GVHD within 7 days prior to Day 1. 3. Concurrent human immunodeficiency virus or active hepatitis B or C infection. 4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5x the upper limit of the normal reference range (ULN), total bilirubin > 3 mg/dL (SI: > 51 µmol/L), or prothrombin time – international normalized ratio (PT-INR) > 2x ULN within 7 days prior to Day 1.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: To evaluate the safety and pharmacokinetics (PK) of selected doses of brincidofovir (BCV) administered intravenously (IV) in allogeneic hematopoietic cell transplant (HCT) recipients with adenovirus (AdV) viremia;Main Objective: The main objective is to evaluate the safety and pharmacokinetics (PK) of selected doses of brincidofovir (BCV) administered intravenously (IV) in allogeneic hematopoietic cell transplant (HCT) recipients with adenovirus (AdV) viremia;Primary end point(s): To evaluate the safety and pharmacokinetics (PK) of selected doses of brincidofovir (BCV) administered intravenously (IV) in allogeneic hematopoietic cell transplant (HCT) recipients with adenovirus (AdV) viremia; Secondary Objective: • To assess the clinical safety of IV BCV with respect to adverse events (AEs) and changes in laboratory parameters. • To assess PK of BCV and cidofovir (CDV) in plasma and CDV diphosphate (CDV-PP) in peripheral blood mononuclear cells (PBMCs) and red blood cells (RBCs) following multiple IV doses of BCV. • To evaluate the virologic response, based on change from baseline in AdV deoxyribonucleic acid (DNA) in plasma and/or stool and incidence of undetectable AdV viremia, of the selected IV BCV doses in HCT recipients.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: To evaluate the safety and pharmacokinetics (PK) of selected doses of brincidofovir (BCV) administered intravenously (IV) in allogeneic hematopoietic cell transplant (HCT) recipients with adenovirus (AdV) viremia;Main Objective: The main objective is to evaluate the safety and pharmacokinetics (PK) of selected doses of brincidofovir (BCV) administered intravenously (IV) in allogeneic hematopoietic cell transplant (HCT) recipients with adenovirus (AdV) viremia;Primary end point(s): To evaluate the safety and pharmacokinetics (PK) of selected doses of brincidofovir (BCV) administered intravenously (IV) in allogeneic hematopoietic cell transplant (HCT) recipients with adenovirus (AdV) viremia; Secondary Objective: • To assess the clinical safety of IV BCV with respect to adverse events (AEs) and changes in laboratory parameters. • To assess PK of BCV and cidofovir (CDV) in plasma and CDV diphosphate (CDV-PP) in peripheral blood mononuclear cells (PBMCs) and red blood cells (RBCs) following multiple IV doses of BCV. • To evaluate the virologic response, based on change from baseline in AdV deoxyribonucleic acid (DNA) in plasma and/or stool and incidence of undetectable AdV viremia, of the selected IV BCV doses in HCT recipients.

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Secondary

Measure	Time frame
Secondary end point(s): • Incidence of TEAEs, particularly those of = CTCAE Grade 3 severity and serious adverse events (SAEs). • Absolute and changes over time in safety laboratory parameters (i.e., hematology and clinical chemistry). • Plasma BCV Cmax, tmax, AUCt, AUClast, AUCinf, %AUCextrap, Clast, tlast, t½, CL, Vz, and Vss following Dose 1 and Dose 4, as data permit. • Change in AdV viremia from baseline. • Relationship between plasma BCV exposure and virologic endpoints of interest and influence of various covariates of interest on the exposure-response relationships and endpoints. ; Timepoint(s) of evaluation of this end point: Safety: through AEs Pharmacokinetics: Day 1 and Day 11 Pharmacodynamics: Day 8 and Day 15	—

Measure

Time frame

Secondary end point(s): • Incidence of TEAEs, particularly those of = CTCAE Grade 3 severity and serious adverse events (SAEs). • Absolute and changes over time in safety laboratory parameters (i.e., hematology and clinical chemistry). • Plasma BCV Cmax, tmax, AUCt, AUClast, AUCinf, %AUCextrap, Clast, tlast, t½, CL, Vz, and Vss following Dose 1 and Dose 4, as data permit. • Change in AdV viremia from baseline. • Relationship between plasma BCV exposure and virologic endpoints of interest and influence of various covariates of interest on the exposure-response relationships and endpoints. ; Timepoint(s) of evaluation of this end point: Safety: through AEs Pharmacokinetics: Day 1 and Day 11 Pharmacodynamics: Day 8 and Day 15

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Countries

Italy, Spain, United States

Contacts

Public ContactChief Medical Officer

Chimerix Inc.

CMX001211ivstudy@chimerix.com+19192876006

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026