Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients

AiCuris

Status and phase: Completed; Phase 2

Conditions: HCMV Reactivation or HCMV End-Organ Disease

Treatments: Drug: 120 mg AIC246; Drug: 60 mg AIC246; Other: Placebo; Drug: 240 mg AIC246

Study type: Interventional

Funder types: Industry

Identifiers

NCT01063829

AIC246-01-II-02

Details and patient eligibility

About

The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Seropositive for HCMV IgG antibodies before transplantation
• First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder
• Evidence of post transplantation engraftment
• Able to swallow tablets.

Exclusion criteria

• Previous anti-HCMV therapy after this allogeneic HBPC transplantation
• Mismatched or cord blood transplant recipients
• Current or history of end-organ HCMV disease
• Graft versus host disease (GVHD)
• Impaired liver function
• Reduced renal function

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 4 patient groups

Dose regimen 1

Experimental group

Description:

60 mg AIC246, one tablet per day

Treatment:

Drug: 60 mg AIC246

Dose regimen 2

Experimental group

Description:

120 mg AIC246, one tablet per day

Treatment:

Drug: 120 mg AIC246

Dose regimen 3

Experimental group

Description:

240 mg AIC246, one tablet per day

Treatment:

Drug: 240 mg AIC246

Placebo

Other group

Description:

Placebo arm

Treatment:

Other: Placebo