EUCTR2006-006148-69-DE进行中（未招募）不适用
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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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