E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pre-emptive treatment for Human cytomegalovirus (HCMV) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary: • Reduction in HCMV DNA load (assessed by PCR) from baseline to Day 15;
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the last patient’s last protocol-defined assessment. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |