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Trial record 1 of 1 for:    NCT00793598
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CMX001 in Post-transplant Patients With BK Virus Viruria

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ClinicalTrials.gov Identifier: NCT00793598
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : July 16, 2021
Last Update Posted : August 16, 2021
Sponsor:
Information provided by (Responsible Party):
Chimerix

Tracking Information
First Submitted Date  ICMJE November 17, 2008
First Posted Date  ICMJE November 19, 2008
Results First Submitted Date  ICMJE June 27, 2021
Results First Posted Date  ICMJE July 16, 2021
Last Update Posted Date August 16, 2021
Actual Study Start Date  ICMJE November 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2021)
Number of Adverse Events in Post-Transplant Patients With BK Virus Viruria [ Time Frame: 35 days (Day 0 to Day 35) ]
The primary objective of this study was to determine the safety and tolerability of brincidofovir (BCV) in post-transplant patients with BK virus viruria. Safety measures included adverse events, clinical laboratory values, vital signs, and renal and gastrointestinal function.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
Safety measures (adverse events, clinical laboratory values, vital signs, renal and gastrointestinal function) [ Time Frame: Multiple time points throughout the study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2021)
  • Percentage of Patients Who Achieved BK Viruria Resolution [ Time Frame: 28 days ]
    The percentage of subjects who cleared the virus was calculated. Concentrations below the lower limit of quantification were indicated as below the limit of quantitation and were considered "cleared".
  • Number of Patients Who Achieved a Clinically Significant Decrease in BK Viruria [ Time Frame: 28 days ]
    A 2-log drop in viruria or viremia or clearance of virus was considered significant. Percentages of subjects with a 2-log drop in viral load were calculated.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
  • PK parameters [ Time Frame: Multiple times, relative to dosing, throughout the study ]
  • BK Viral load (urine and plasma) [ Time Frame: Throughout the course of the study ]
  • Patient drop-out rate [ Time Frame: Through out the course of the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CMX001 in Post-transplant Patients With BK Virus Viruria
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of the Safety, Tolerability and Population Pharmacokinetics of CMX001 in Post-Transplant Subjects With BK Virus Viruria
Brief Summary This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus viruria.
Detailed Description

This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus infection.

Subjects received blinded study medication for a total of 5 doses in 1 of the following regimens:

  • 10 mg BCV administered twice weekly (BIW) on Days 0, 3, 7, 10, 14.
  • 20 mg BCV administered once weekly (QW) on Days 0, 7, and 14 and placebo administered on Days 3 or 10.
  • Placebo administered BIW on Days 0, 3, 7, 10 ,14.
  • 40 mg BCV administered QW on Days 0, 7, 14, 21, and 28.
  • Placebo administered QW on Days 0, 7, 14, 21, and 28.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Viruria
Intervention  ICMJE
  • Drug: Placebo
  • Drug: Brincidofovir
    Other Names:
    • BCV
    • CMX001
Study Arms  ICMJE
  • Experimental: Brincidofovir

    Under Amendments 1 and 2, subjects received 1 of 2 dose regimens of brincidofovir, as follows:

    • 20 mg BCV once weekly (QW) on Days 0, 7, and 14; or
    • 10 mg BCV twice weekly (BIW) BIW on Days 0, 3, 7, 10, and 14.

    Under Amendment 3, subjects received 40 mg BCV QW for a total of 5 doses on Days 0, 7, 14, 21, and 28.

    Intervention: Drug: Brincidofovir
  • Placebo Comparator: Placebo

    Under Amendments 1 and 2, subjects received placebo twice weekly (BIW) for a total of 5 doses on Days 0, 3, 7, 10, and 14.

    Under Amendment 3, subjects received placebo once weekly (QW) for a total of 5 doses on Days 0, 7, 14, 21, and 28.

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2021)
29
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2008)
32
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

For inclusion into the trial, subjects were required to fulfill all of the following criteria:

  1. Aged between 18 to 75 years, inclusive. Males must have been able and willing to use adequate contraceptive methods throughout the study and for 3 months after the final dose. Females must have been post-menopausal, surgically sterile, or willing to use adequate contraception for the duration of the study (screening through the Day 48 visit).
  2. Were renal or hematopoietic stem cell transplant patients who met the following criteria:

    1. Renal transplant patients who:

      • Were at least 28 days post transplant;
      • Were in stable condition with hemoglobin >10 g/100 mL;
      • Had no evidence of graft rejection (i.e., serum creatinine was not increasing [±30%], creatinine clearance was not decreasing);
      • Were on a stable immunosuppressant regimen for at least 14 days prior to dosing.
      • Had either urine levels of BK virus DNA ≥10^4 copies/mL without viremia or plasma levels of BK virus DNA <10^4 copies/mL (with or without viruria).
    2. Stem cell transplant patients who:

      • Were a minimum of 3 days post documentation of successful engraftment as evidenced by an absolute neutrophil count >500 cells/mm3;
      • Had urine levels of BKV ≥10^4 copies/mL.
  3. Had GFR >30 mL/min.
  4. Were able to swallow tablets.
  5. Were willing and able to understand and provide written informed consent.
  6. Were willing and able to participate in all required study activities for the duration of the study (including ingestion of oral medication).

Exclusion Criteria

Any of the following was regarded as a criterion for exclusion from the trial:

  1. Females who were currently nursing or pregnant.
  2. Were using illicit drugs or abusing alcohol.
  3. Had hypersensitivity to cidofovir or brincidofovir.
  4. Had received aminoglycosides (intravenously) or NSAIDS (except as given for cardioprotective treatment) within 7 days prior to enrollment; had received leflunomide, cidofovir, or any other medication for treatment of BK virus infection or disease within 14 days prior to enrollment; had received any investigational drug (including maribavir) within 30 days prior to enrollment.
  5. Were HIV positive (results must have been obtained within 1 year prior to dosing); had active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection as evidenced by plasma levels of HCV RNA or HBV DNA, respectively.
  6. Were renal transplant patients with evidence of biopsy proven acute rejection in the 3 weeks prior to enrollment. This exclusion criterion applied only to those patients for whom a biopsy was performed within the 3 weeks prior to enrollment.
  7. Were stem cell transplant patients who:

    1. Had cystitis ≥Grade 3 National Cancer Institute, Common Terminology Criteria for Adverse Events version 3.0.
    2. Had Grade 3 or 4 graft versus host disease (GVHD).
    3. Had untreated or uncontrolled Grade 2 GVHD.
    4. Had received ganciclovir or valganciclovir within 14 days prior to enrollment.
  8. Had mucositis that prevented ingestion of oral medication.
  9. Had hypotony, uveitis, or retinitis or any intraocular pathology that would have predisposed the patient to any one of these conditions.
  10. Had unstable or poorly controlled diabetes, defined as having frequent hypoglycemic and/or hyperglycemic events on a daily basis (brittle diabetes), with fluctuating short acting insulin requirements daily, or requiring unpredictable insulin supplementation to oral hypoglycemic agents on a regular basis.
  11. Had bilirubin >2.5 x the upper limit of normal.
  12. Had cardiovascular disease which, in the opinion of the investigator, would have interfered with the conduct of the study.
  13. Had any of the following autoimmune diseases: Addison's disease, autoimmune hemolytic anemia, autoimmune hepatitis, bullous pemphigoid, celiac disease, dermatomyositis, active Goodpasture's syndrome, idiopathic thrombocytopenic purpura, active lupus erythematosus, multiple sclerosis, myasthenia gravis, pemphigus vulgaris, polymyositis, primary biliary cirrhosis, vasculitis, Wegener's granulomatosis.
  14. Had active malignancies (with the exception of basal cell carcinoma or the condition under treatment for hematopoietic stem cell transplant patients).
  15. Had concurrent or ongoing ≥Grade 2 gastrointestinal symptoms including nausea, vomiting, diarrhea, constipation, or gastroenteritis. Patients with active gastrointestinal disease including inflammatory bowel disease, irritable bowel syndrome, or celiac sprue.
  16. Had any other condition including abnormal laboratory values that would have, in the judgement of the investigator, put the subject at increased risk for participating in the trial, or interfered with the conduct of the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793598
Other Study ID Numbers  ICMJE CMX001-104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chimerix
Original Responsible Party Neil Frazer/ Chief Medical Officer, Chimerix
Current Study Sponsor  ICMJE Chimerix
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chimerix
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP