Phase 2a Randomized, Controlled, Multi-center, Open-label Dose Ranging Proof of Concept Study to Evaluate the Safety, Tolerability and Antiviral Activity of AIC-001 Over 14 Days of Dosing in Patients With Positive HCMV Viremia Under the Conditions of a Pre-emptive Strategy.
- Conditions
- Pre-emptive treatment for Human cytomegalovirus (HCMV)
- Registration Number
- EUCTR2006-006148-69-DE
- Lead Sponsor
- AiCuris GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method