Pre-emptive treatment for Human cytomegalovirus (HCMV)
Conditions
Interventions
Product Name: AIC-001 Coprecipitate Tablets
Product Code: AIC-001
Pharmaceutical Form: Tablet
Current Sponsor code: AIC-001
Other descriptive name: BAY 73-6327, BAY 73-6327 N
Concentration unit: mg mi
Sponsors
AiCuris GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed written informed consent; • Are able and willing to comply with protocol requirements; • At least 18 years of age at screening; • Male patients, who must agree to using an acceptable form of contraception, i.e. double-barrier methods, with their sexual partner during participation in the study and for 3 months after the end-of-study visit; or Female patients, who are post-menopausal (older than 50 years of age who have a history of no menses for at least 24 months) or surgically sterile; • Positive for HCMV in blood (tested for at the local laboratory) and eligible for pre-emptive therapy according to local practice; • Transplant recipient for kidney and kidney/pancreas. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients not meeting the inclusion criteria; • Patients who have already received AIC-001 treatment; • Hepatitis B surface antigen positive, and/or hepatitis B virus (HBV) DNA positive; • Human immunodeficiency virus (HIV) positive; • Patients with current severe systemic infection; • Patients with symptomatic end-organ HCMV disease; • Patients with graft versus host disease (GVHD) at enrollment* (Grade III-IV); • Patients with multi-organ transplant, other than that allowed per inclusion criteria; • Reduced liver function (indicated by transaminase elevations up to 3 x ULN in the 7 days prior to enrollment*); • Reduced renal function (indicated by a creatinine of >3.5 mg/dL in the 7 days prior to enrollment*); • Presence of neutropenia (indicated by a neutrophil count <500/mm3 in the 7 days prior to enrollment*); • Reduced number of platelets (indicated by <2 x 104 platelets/?L in the 7 days prior to enrollment*); • Hemoglobin count <8 g/dL in the 7 days prior to enrollment*; • Uncontrolled diarrhea or severe gastrointestinal disease, which would preclude oral medication; • Women of child-bearing potential; • Participation in another investigational study with an experimental drug within the 30 days prior to screening; • Patients receiving treatment with CYP3A4 inducers or inhibitors including but not limited to: amiodarone, diltiazem or other calcium channel blockers, cimetidine, ketoconazole, fluconazole, carbamazepine, barbiturates (e.g. phenobarbital), phenytoin, erythromycin or other macrolide antibiotics; patients on cyclosporine, tacrolimus, everolimus, amlodipine, verapamil, and nitrendipine are the exceptions; • Have had previous HCMV treatment with ganciclovir or valganciclovir within 4 days prior to enrollment*, or with cidofovir or foscarnet within the 30 days prior to enrollment*; • Have any clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements. *enrollment = randomization to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: • To determine the decline in HCMV DNA load after a 14-day treatment for each AIC-001 dosing regimen and to compare this to an observational control group. ;Secondary Objective: The secondary objectives of this study are: • To assess the safety, pharmacokinetics, tolerability and efficacy of the AIC-001 dosing regimens and to compare this to an observational control group. ;Primary end point(s): Primary: • Reduction in HCMV DNA load (assessed by PCR) from baseline to Day 15; | — |
Countries
Germany
Outcome results
None listed