EUCTR2012-004792-39-DE进行中（未招募）1 期
Open-label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adult Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection (CORAL-I).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
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
- •1. Male or female, at least 18 years of age at the time of screening.
- •2. Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine.
- •Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 10 mg / day.
- •3. HCV IFN therapy treatment-naïve or experienced, either pre or post liver or renal transplant.
- •4. Screening HCV genotype testing indicating infection with genotype 1 HCV only.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of Screening Visit.
- •2. Use of any medications listed below as well as those that are contraindicated for use with either ritonavir or RBV within 2 weeks prior to study drugs administration or 10 half-lives (if known), whichever is longer, including but not limited to:
- •Atorvastatin
- •Carbamazepine
- •Enzalutamide
- •Systemic estrogen-containing medications
- •Fusidic acid
- •Gemfibrozil
- •Posaconazole
- •Clarthromycin
- •Colchicine in patients with renal or hepatic impairment
- •Ergot derivatives (Dihydroergotamine, Ergotamine, Ergonovine,
- •Methylergometrine)Efavirenz
- •Itraconazole
- •Ketoconazole
- •Lopinavir/ritonavir
- •Midazolam (oral)Mitotane
- •Phenobarbital
- •Sildenafil*
- •Simvastatin
- •St. John's Wort
- •Telithromycin
- •Terfenadine
- •Voriconazole
- •* When used for the treatment of pulmonary arterial hypertension.Note: Not all medications contraindicated with ritonavir and ribavirin arelisted above. Refer to themost current package inserts or product labelling of ritonavir and ribavirin for a complete list ofcontraindicated medications.
研究者
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