A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
- •HCV RNA infection with quantifiable virus at screening
- •Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
- •Currently on the liver transplantation wait list
- •Screening electrocardiogram (ECG) without clinically significant abnormalities.
- •A negative serum pregnancy test result is required for females
排除标准
- •Any previous solid organ transplant
- •Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
- •HIV infection or a positive hepatitis B virus surface antigen result
- •History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
- •Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
- •Prior exposure to an HCV non-structural protein (NS)5A inhibitor
- •Patients on hemodialysis prior to or at the time of transplantation will be excluded
- •Creatinine clearance (CLcr) < 40 mL/min at screening or < 40 mL/min on day of transplant
- •Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit
- •Receipt or planned receipt of an organ from an HCV positive donor
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LDV/SOF
Participants with genotype 1 or 4 HCV who are undergoing liver transplant will receive one dose of LDV/SOF prior to the transplant and then will receive LDV/SOF once daily for 4 weeks following the transplant.
干预措施: LDV/SOF (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event
时间窗: Up to 4 weeks
次要结局
- Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 12)
- Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28(Days 1, 3, 5, 7, 14, 21, and 28)