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

Shire

Status and phase: Completed; Phase 2

Conditions: Cytomegalovirus (CMV)

Treatments: Drug: Maribavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01611974

SHP620-202 (Other Identifier)

1263-202

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Maribavir 400 mg twice daily

Experimental group

Treatment:

Drug: Maribavir

Maribavir 800 mg twice daily

Experimental group

Treatment:

Drug: Maribavir

Maribavir 1200 mg twice daily

Experimental group

Treatment:

Drug: Maribavir