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The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation (AdAPT)

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ClinicalTrials.gov Identifier: NCT03339401
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Adenovirus Other: Standard of Care Drug: Brincidofovir Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : September 21, 2019
Estimated Study Completion Date : February 21, 2020
Arms and Interventions

Arm Intervention/treatment
Experimental: Brincidofovir (BCV)
BCV
Drug: Brincidofovir
BCV
Other Name: BCV
Standard of Care (SOC)
SOC
Other: Standard of Care
SOC per study center guidelines
Other Name: SOC


Outcome Measures

Primary Outcome Measures :
  1. Primary Outcome is the time-averaged area under the concentration-time curve (AAUC) for plasma AdV viremia (log10 copies/mL). [ Time Frame: randomization through16 weeks ]
    From randomization through Week 16, time-averaged area under the concentration-time curve (AAUC) for plasma AdV viremia (log10 copies/mL).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged at least 2 months and less than 18-years-old on Day 1 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. AdV DNA plasma viremia of ≥ 1,000 copies/mL and rising, defined as two consecutive results ≥ 1,000 copies/mL from the designated central virology laboratory, with the second result being greater than the first.

Exclusion Criteria:

  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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339401


Contacts
Contact: Garrett Nichols, MD, MS 919-287-6006 gnichols@chimerix.com

Locations
United States, Ohio
Cincinnati Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: Michael Grimley, MD         
Sponsors and Collaborators
Chimerix
More Information

Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT03339401     History of Changes
Other Study ID Numbers: CMX001-999
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adenoviridae Infections
DNA Virus Infections
Virus Diseases