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
  Purpose

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.


Condition Intervention Phase
Cytomegalovirus Infections
Drug: Maribavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Number of subjects with treatment emergent adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of subjects with undetectable plasma CMV [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maribavir 400 mg twice daily Drug: Maribavir
Tablet for oral administration
Experimental: Maribavir 800 mg twice daily Drug: Maribavir
Tablet for oral administration
Experimental: Maribavir 1200 mg twice daily Drug: Maribavir
Tablet for oral administration

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611974

  Show 32 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Stephen A. Villano, M.D. ViroPharma Incorporated
  More Information

No publications provided by Shire

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01611974     History of Changes
Other Study ID Numbers: 1263-202
Study First Received: June 1, 2012
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
CMV
cytomegalovirus
resistant
refractory
transplant
treatment

Additional relevant MeSH terms:
Communicable Diseases
Cytomegalovirus Infections
Infection
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014