NL-OMON30363已完成3 期
A twelve-month, multicenter, randomized, open-label study of safety, tolerability and efficacy of Certican-based regimen versus calcineurin inhibitor-based regimen in de novo liver transplant recipient - Certican versus calcineurin inhibitor in de novo liver transplant
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Males or females 18 - 70 years old
- •2. Liver transplant recipient (living or deceased donor)
- •3. Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
- •4. Patients in whom an allograft biopsy will not be contraindicated
- •5. Females capable of becoming pregnant must have a negative pregnancy test prior to start of study and are required to practice a medically approved method of birth control for the duration of the study
- •6. Patients with cGFR > 50 ml/min
排除标准
- •1. Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
- •2. HCV positive patients who need an active anti-viral treatment (HCV-positive patients without active antiviral treatment are allowed)
- •3. HIV positive patients
- •4. Patients who are breast feeding
- •5. Patients with a current severe systemic infection
- •6. Patients who have received an unlicensed drug or therapy within one month prior to study entry
- •7. Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
- •8. Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation.
- •9. Patients that have received Simulect prior to this study.
- •10. Patients that have received any immunosuppressive regimen 2 months prior to this study.
研究者
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