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OpenTrials
Completed

NCT Number: NCT01063829

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

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).

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Key information

Conditions

HCMV Reactivation or HCMV End-Organ Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitaetsklinikum Dresden, Dresden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

60 mg AIC246

Drug

Oral administration

120 mg AIC246

Drug

Oral administration

240 mg AIC246

Drug

Oral administration

Placebo

Other

Oral administration

Primary outcomes

  1. Number of Participants With "HCMV Prophylaxis Failure"

    Time frame: 84 days

  2. Time to Onset of "HCMV Prophylaxis Failure"

    Time frame: 84 days

Secondary outcomes

  1. Number of Patients With Systemic Detectable HCMV Replication.

    Time frame: 84 days

Sponsors and collaborators

Lead sponsor

AiCuris Anti-infective Cures AG

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 5, 2010
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.