Summary

for people ages 2 months to 17 years (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

This study is designed to assess the safety, overall tolerability, and antiviral activity of "short course" BCV therapy, as compared with current standard of care (SoC), for the treatment of adenovirus (AdV) infections in high-risk (i.e., T cell depleted) pediatric allogeneic hematopoietic cell transplant (HCT) recipients. A virologic response-driven approach to the duration of treatment will be evaluated, in which subjects randomized to BCV therapy are treated until AdV viremia is confirmed as undetectable or until a maximum of 16 weeks of therapy, whichever occurs first.

Official Title

An Open-label, Randomized, Multi-center, Parallel Group, Two-arm Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir Versus Standard of Care for Treatment of Adenovirus Infections in High-risk Pediatric Allogeneic Hematopoietic Cell Transplant Recipients

Keywords

AdenovirusAdenoviridae InfectionsStandard of CareBrincidofovirBrincidofovir (BCV)

Eligibility

You can join if…

Open to people ages 2 months to 17 years

  1. Aged at least 2 months and less than 26 years-old on Day 1 (US only) ages 2 months or less than 18 years old on day one (ROW) AND
  2. Have received a T cell-depleted allogeneic (i.e., non-autologous) HCT within the previous 100 days.
  3. First detectable AdV DNA plasma viremia since the qualifying transplant occurred within 21 days prior to Day 1.
  4. Have EITHER:

A) Confirmed AdV viremia of ≥ 1000 copies/mL and rising, defined as two consecutive AdV DNA polymerase chain reaction (PCR) test results ≥ 1000 copies/mL from the designated central virology laboratory, with the second result being greater than the first. The second sample must be drawn at least 48 hours after the first sample and no more than 7 days prior to Day 1. OR B) Single AdV viremia measurement of ≥ 10,000 copies/mL reported by the designated central virology laboratory from a sample drawn no more than 7 days prior to Day 1.

You CAN'T join if...

  1. Any CTCAE Grade 4 diarrhea (i.e., life-threatening consequences with urgent intervention indicated) within 7 days prior to Day 1
  2. Any CTCAE Grade 2 or 3 diarrhea (i.e., increase of ≥ 4 stools per day over baseline), unless attributed to AdV, within 7 days prior to Day 1
  3. NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1
  4. NIH Stage 2 or higher acute GVHD of the liver (i.e., bilirubin > 3 mg/dL [SI: > 51 μmol/L]) within 7 days prior to Day 1
  5. NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea > 556 mL/m2/day, or severe abdominal pain with or without ileus) within 7 days prior to Day 1
  6. Active malignancy (with the exception of non-melanoma skin cancer), including relapse or progression of the underlying disease for which qualifying transplant was performed
  7. Use of vasopressors within 7 days prior to Day 1
  8. PT-INR > 2x upper limit of normal reference range (ULN) in the absence of anticoagulation within 7 days prior to Day 1
  9. Requirement for mechanical ventilation within 7 days prior to Day 1, or sustained oxygen delivery for > 24 hours within 7 days prior to Day 1, or any oxygen requirement within 48 hours prior to Day 1
  10. . Estimated creatinine clearance < 30 mL/min or use of renal replacement therapy (e.g., hemodialysis, continuous renal replacement therapy, peritoneal dialysis) within 7 days prior to Day 1
  11. . ALT > 5x ULN, AST > 5x ULN, or total bilirubin > 3 mg/dL [SI: > 51 μmol/L] within 7 days prior to Day 1
  12. . Human immunodeficiency virus (HIV) infection as detected through any laboratory method (e.g., enzyme-linked immunosorbent assay, Western Blot, RNA PCR). [Note: Testing to confirm the absence of HIV infection is required at screening unless testing was performed by the local laboratory within 6 months prior to screening.]
  13. . Females who are pregnant or breastfeeding or planning to become pregnant within 90 days after their last anticipated dose of BCV
  14. . Receiving or anticipated to receive medications prohibited in the protocol.
  15. . Hypersensitivity (not including renal dysfunction or eye disorder) to CDV or to BCV or its formulation excipients
  16. . Participation in another interventional clinical trial unless prior approval has been received from the Chimerix Medical Monitor (or designee).
  17. . Received any cell-based anti-AdV therapy within 6 weeks prior to Day 1 or previously received an anti-AdV vaccine at any time.

Locations

  • University of California San Francisco accepting new patients
    San FranciscoCalifornia94143United States
  • Children's Hospital of Los Angeles accepting new patients
    Los AngelesCalifornia90027United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Chimerix
ID
NCT03339401
Phase
Phase 2
Study Type
Interventional
Last Updated