Phase 2 N=131 Randomized Quadruple-blind Prevention

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

HCMV Reactivation or HCMV End-Organ Disease

Bottom Line

View on ClinicalTrials.gov: NCT01063829 ↗

Enrolled (actual)

131

Serious AEs

42.8%

Results posted

Feb 2018

Primary outcome: Primary: Number of Participants With "HCMV Prophylaxis Failure" — 16; 10; 10; 21 Participants — p=0.007

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 60 mg AIC246 (Drug); 120 mg AIC246 (Drug); 240 mg AIC246 (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AiCuris Anti-infective Cures AG
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With "HCMV Prophylaxis Failure"	16; 10; 10; 21	0.007 sig
PRIMARY Time to Onset of "HCMV Prophylaxis Failure"	7; 6; 2; 12	0.002 sig
SECONDARY Number of Patients With Systemic Detectable HCMV Replication.	7; 5; 2; 12	0.007 sig

Summary

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01063829). 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.