Phase 2
Completed N=120
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
Cytomegalovirus (CMV)
Source: ClinicalTrials.gov NCT01611974 ↗
Enrolled (actual)
120
Serious AEs
67.5%
Results posted
Dec 2015
Primary outcomePrimary: Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks — 28; 25; 27 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks |
28; 25; 27 | — |
| PRIMARY Number of Participants With a Treatment Emergent Adverse Event (TEAE). |
40; 40; 40; 28; 27; 26 | — |
| SECONDARY Number of Participants With CMV Recurrence |
7; 11; 12 | — |
| SECONDARY Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study |
24.0; 28.0; 22.0; 24.0; 28.0; 22.0 | — |
| SECONDARY Time to CMV Recurrence |
NA; 118.0; 161.0 | — |
| SECONDARY Maximum Concentration (Cmax) of Maribavir |
18.5; 35.1; 45.1; 17.8; 25.0; 35.6 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Maribavir |
3.56; 2.70; 2.81; 1.66; 3.23; 3.12 | — |
| SECONDARY Time of Last Non-Zero Concentration (Tlast) of Maribavir |
9.03; 8.26; 8.71; 7.37; 7.99; 8.61 | — |
| SECONDARY Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir |
100; 179; 264; 90.9; 139; 207 | — |
| SECONDARY Half-Life (T½) of Maribavir |
5.56; 6.08; 7.77; 4.32; 6.34; 5.33 | — |
Eligibility Criteria
Inclusion Criteria
- Be ≥12 years of age.
- Weigh ≥ 40 kg.
- Be a recipient of stem cell or solid organ transplantation.
- Have documented CMV infection in blood or plasma, with a screening value of ≥1,000 DNA copies/mL.
- 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.
- If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test prior to randomization.
- Be able to swallow tablets.
- 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).
- 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
- Be receiving any other anti-CMV agent(s).
- Have a current CMV infection that is considered resistant or refractory due to inadequate adherence to prior oral anti-CMV treatment.
- Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the time of enrollment.
- Have severe hepatic impairment.
- Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
- Have expected survival less than 6 weeks.
- Be pregnant or breastfeeding.
- Other clinically significant medical or surgical condition.
Data sourced from ClinicalTrials.gov (NCT01611974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.