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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339401
Recruitment Status : Terminated (terminated due to low enrollment rate)
First Posted : November 13, 2017
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Chimerix

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 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
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 10, 2019

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




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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.

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.

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


Locations
Show Show 36 study locations
Sponsors and Collaborators
Chimerix
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Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT03339401    
Other Study ID Numbers: CMX001-999
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoviridae Infections
DNA Virus Infections
Virus Diseases