Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01611974
First received: June 1, 2012
Last updated: October 9, 2014
Last verified: March 2014

June 1, 2012
October 9, 2014
July 2012
September 2014   (final data collection date for primary outcome measure)
Number of subjects with treatment emergent adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01611974 on ClinicalTrials.gov Archive Site
Number of subjects with undetectable plasma CMV [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
A Phase 2, Randomized Study to Assess the Safety and Anti-cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections That Are Resistant or Refractory to Treatment With Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipients

This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in recipients of stem cell or solid organ transplants.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cytomegalovirus Infections
Drug: Maribavir
Tablet for oral administration
  • Experimental: Maribavir 400 mg twice daily
    Intervention: Drug: Maribavir
  • Experimental: Maribavir 800 mg twice daily
    Intervention: Drug: Maribavir
  • Experimental: Maribavir 1200 mg twice daily
    Intervention: Drug: Maribavir
Schubert A, Ehlert K, Schuler-Luettmann S, Gentner E, Mertens T, Michel D. Fast selection of maribavir resistant cytomegalovirus in a bone marrow transplant recipient. BMC Infect Dis. 2013 Jul 19;13:330. doi: 10.1186/1471-2334-13-330.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
December 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Be ≥12 years of age.
  2. Weigh ≥ 40 kg.
  3. Be a recipient of stem cell or solid organ transplantation.
  4. Have documented CMV infection in blood or plasma, with a screening value of ≥1,000 DNA copies/mL.
  5. Have a current CMV infection that is resistant (known CMV genetic mutations) or refractory (clinical failure to respond) to treatment with ganciclovir/valganciclovir and/or foscarnet.
  6. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test prior to randomization.
  7. Be able to swallow tablets.
  8. If adult, provide written informed consent. If child (age <18 years), have a parent/legal guardian who is willing and able to provide written informed consent (with assent from the child when appropriate).
  9. Be assessed by the investigator to determine whether prophylaxis for non-CMV herpesvirus infections (e.g., herpes simplex virus [HSV type 1 and type 2] and varicella zoster virus [VZV]) is appropriate according to institutional guidelines or standard practices, keeping in mind that maribavir is not active in vitro against these viruses.

Exclusion Criteria

  1. Be receiving any other anti-CMV agent(s).
  2. Have a current CMV infection that is considered resistant or refractory due to inadequate adherence to prior oral anti-CMV treatment.
  3. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the time of enrollment.
  4. Have severe hepatic impairment.
  5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
  6. Have expected survival less than 6 weeks.
  7. Be pregnant or breastfeeding.
  8. Other clinically significant medical or surgical condition.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01611974
1263-202
Yes
Shire
Shire
Not Provided
Study Director: Stephen A. Villano, M.D. ViroPharma Incorporated
Shire
March 2014

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