Clinical Trials Logo

Clinical Trial Summary

This was a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study of brincidofovir (BCV) administered orally once or twice weekly for up to 11 weeks. Dosing was initiated immediately following engraftment (between Days 14-30 post-transplant) to prevent/control cytomegalovirus (CMV) infection or prevent disease in R+ hematopoietic stem cell transplant (HCT) recipients.


Clinical Trial Description

This was to be a 2-part study. Part 1 was a randomized, double-blind, placebo-controlled, dose-escalation study of multiple doses of oral brincidofovir (BCV) in R+ hematopoietic stem cell transplant (HCT) recipients. In Part 2, one of the dose levels administered in Part 1 was to be tested against placebo to evaluate the statistical significance of BCV as a therapy for preventing progression of cytomegalovirus (CMV) infection or preventing CMV disease. The first 3 dose-escalating cohorts in Part 1 were to include 32 subjects within each cohort (24 randomized to receive oral BCV and 8 randomized to receive placebo in a 3:1 ratio) for a total of 96 planned subjects. Following completion of the first 3 cohorts and subsequent safety review of the data, up to an additional 3 cohorts of 32 subjects each could have been enrolled. Two additional cohorts (labeled Cohort 4 and Cohort 4A) beyond the initial 3 cohorts were actually enrolled in Part 1 of the study. Following the safety and antiviral activity analyses of the 5 cohorts in Part 1 and the number of subjects enrolled in each of those cohorts, Part 2 of the study was not conducted. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00942305
Study type Interventional
Source Chimerix
Contact
Status Completed
Phase Phase 2
Start date October 2009
Completion date January 2012

See also
  Status Clinical Trial Phase
Completed NCT00023036 - Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts
Terminated NCT01037712 - In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir Phase 4
Completed NCT00370006 - Phase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM Phase 1
Completed NCT01552369 - CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL") Phase 4
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Completed NCT00223925 - Maribavir for Prevention of CMV After Stem Cell Transplants Phase 2
Active, not recruiting NCT05085366 - A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age Phase 3
Completed NCT01220895 - Alternate Donor Study of Pre-Emptive Cellular Therapy Phase 2
Completed NCT00373412 - Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge Phase 1
Completed NCT05105048 - A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 Phase 1
Completed NCT00386412 - TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant Phase 2
Completed NCT03382405 - Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults Phase 1
Completed NCT02454699 - Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers Phase 1
Active, not recruiting NCT03910478 - Dried Blood Spot Testing of CMV Detection in HCT Recipients N/A
Completed NCT01354301 - Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate Phase 4
Active, not recruiting NCT01473849 - Impact of Cytomegalovirus (CMV) Replication Over Hepatitis C Recurrence in Liver Transplant Recipients N/A
Completed NCT00880789 - Safety, Toxicity and MTD of One Intravenous IV Injection of Donor CTLs Specific for CMV and Adenovirus Phase 1
Completed NCT00817908 - Quantiferon - Cytomegalovirus (CMV) and the Prediction of CMV Infection In High Risk Solid Organ Transplant Recipients N/A
Completed NCT00273143 - A Trial to Study How the Body Fights Off Cytomegalovirus (CMV) in Hematopoietic Transplant Recipients. Phase 1
Completed NCT00194155 - Cytomegalovirus (CMV) Infection in Pregnancy N/A