MedTrace Logo

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

NCT01063829 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2018-02-13

Study results available
· View outcomes & findings →

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).

Conditions

  • HCMV Reactivation or HCMV End-Organ Disease

Interventions

DRUG

60 mg AIC246

Oral administration

DRUG

120 mg AIC246

Oral administration

DRUG

240 mg AIC246

Oral administration

OTHER

Placebo

Oral administration

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AiCuris Anti-infective Cures AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063829 on ClinicalTrials.gov