NCT01063829

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

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT01063829

Principal Investigator:

Study Type:

INTERVENTIONAL

Official 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

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

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

Disease(s) and\or Condition(s)

HCMV Reactivation or HCMV End-Organ Disease

Primary Purpose

PREVENTION

Intervention/Treatment

- Type: DRUG
- Name: 60 mg AIC246
- Description: Oral administration
- Arm Group Labels: Dose regimen 1
- Type: DRUG
- Name: 120 mg AIC246
- Description: Oral administration
- Arm Group Labels: Dose regimen 2
- Type: DRUG
- Name: 240 mg AIC246
- Description: Oral administration
- Arm Group Labels: Dose regimen 3
- Type: OTHER
- Name: Placebo
- Description: Oral administration
- Arm Group Labels: Placebo

Sponsor

AiCuris Anti-infective Cures AG