A Study of the Safety of Intravenous Brincidofovir for Adenovirus Infectio

Phase 1

• 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; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-003984-37-ES
• Lead Sponsor: Chimerix, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified