A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection

Launched by SYMBIO PHARMACEUTICALS · Jan 11, 2021

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called intravenous brincidofovir (BCV) for patients with adenovirus (AdV) infections and cytomegalovirus (CMV) infections. The goal is to find out if BCV is safe and how well it works. Participants in the trial will receive BCV at different doses twice a week or once a week for four weeks. The researchers are looking for people aged 2 months and older who have a high level of AdV or CMV in their blood and may have serious health issues that require treatment.

To be eligible, participants must have specific test results indicating a significant viral presence and may have either widespread AdV disease or a weakened immune system. However, individuals who weigh over 120 kg or have certain serious health conditions, like severe diarrhea or acute graft-versus-host disease, cannot participate. Those who join the study can expect close monitoring by healthcare professionals and will be contributing to research that might help improve treatment for future patients with these infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, aged 2 months and older at the time of informed consent.
• • AdV DNA viremia \>10,000 copies/mL from a single sample, or 2 samples greater than 48 hours apart with the second result higher than the first and both greater than 1000 copies/mL, from the data obtained from the designated central virology laboratory of the local laboratory using the blood sample(s) collected informed consent has been obtained and within 7 days prior to Day 1 (AdV DNA viremia results collected within the 7 day window, but prior to consent may be used if the Informed Consent Form (ICF) signed by the subject provides approval) . CMV viremia with or without evidence of tissue invasive CMV disease. For laboratory results that are generated in units other than copies/mL or IU/mL, please refer to the testing laboratory for guidance on the appropriate conversion calculation.
• • Either (a) have disseminated AdV disease or (b) have an underlying immunocompromised state, and have asymptomatic AdV infection or localized AdV disease.
• • In the judgment of the investigator, be in a serious condition to be treated with intravenous cidofovir for AdV.
• Exclusion Criteria:
• • Subjects who weigh ≥120 kg.
• • NIH/NCI CTCAE (United States \[US\] National Institutes of Health \[NIH\]/National Cancer Institute) Grade 2 or higher diarrhea (i.e., increase of ≥ 4 stools per day over usual pre-transplant stool output) within 7 days prior to Day 1.
• • NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1.
• • NIH Stage 2 or higher acute GVHD of the liver function (i.e., bilirubin \>3 mg/dL \[SI: \>51 μmol/L\]) within 7 days prior to Day 1.
• • NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea \>556 mL/m2/day for pediatric subjects \[or \>1000 mL/day for young adults as applicable, at centers in the United States only\], or severe abdominal pain with or without ileus) within 7 days prior to Day 1.