Maribavir 12 months Chart Review

• Research type

  Research Study

• Full title

  Retrospective Study to Collect Follow-Up Data at 12 Months Among Transplant Recipients with Refractory or Resistant Cytomegalovirus Infections Randomized to the Maribavir Treatment Arm in the SHP620-303 Open-label Phase III Trial

• IRAS ID

  294812

• Contact name

  Mark Harber

• Contact email

  mark.harber@nhs.net

• Sponsor organisation

  Takeda Development Center Americas

• Duration of Study in the UK

  1 years, 2 months, 29 days

• Research summary

  Summary of Research
  Cytomegalovirus (CMV) is a member of the beta herpesviruses group and, although CMV infection is usually asymptomatic, it can lead to severe outcomes in immunosuppressed individuals, such as patients undergoing transplants.

  Currently, there are limited options for treating or preventing CMV infections in transplant recipients. The effectiveness of ganciclovir, valganciclovir, foscarnet, and cidofovir are limited by their respective toxicities. Furthermore, the development of resistance to anti-CMV agents is commonly reported. CMV infections that are refractory or resistant to currently available antivirals are a major cause of morbidity and mortality among transplant recipients. There is a need for novel therapies among transplant recipients whose CMV infections are refractory or resistant to currently available antiviral treatments.

  Maribavir is an antiviral drug that is part of a new class of anti-CMV agents. The safety, tolerability, and antiviral activity of maribavir has been previously shown in the phase II trial (SHP620-202) of resistant or refractory CMV infections following transplant. A phase III, open-label, superiority trial (SHP620-303) is also underway and has now been completed.

  The duration of the SHP620-303 trial is 20 weeks; however, some health technology assessment bodies require longer-term data. In particular, data (beyond 20 weeks) regarding patient status (overall survival) and transplant status. This observational, retrospective chart review study will, therefore, be conducted to evaluate the long-term clinical outcomes (up to 12 months from maribavir treatment initiation) among transplant recipients with refractory or resistant CMV infections who were randomised to the maribavir treatment arm in the SHP620-303 trial. The data collection as part of the retrospective chart review will include additional post-trial data following the SHP620-303 study. The total follow-up, combining SHP620-303 trial data and retrospective chart review data collections, will consequently cover a period of 52 weeks (i.e., 12 months) post-maribavir treatment initiation.

  The study aims to collect additional data on clinical outcomes on CMV treatment from patient medical records over a period of post-trial completion for approximately 157 maribavir-treated transplant recipients.

  Summary of Results
  Not Available

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/PR/0256

• Date of REC Opinion

  30 Mar 2021

• REC opinion

  Favourable Opinion