Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant
研究概览
简要总结
The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant.
Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at different stages of the HCV infection to stop the virus.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take telaprevir 3 times a day. You will take RVB by mouth 2 times a day. You will receive PEGIFN alfa-2a by an injection under the skin 1 time a week.
Study Visits:
On the first day you take the study drug:
- You will have an eye exam performed by the study doctor.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis virus.
- You will be asked about any drugs you are taking or side effects you may be having.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥ 18 and ≤ 70 years
- •Detectable Hepatitis C Virus ribonucleic acid (HCV-RNA) in serum
- •HCV genotype 1 infection
- •Child-Pugh-Turcotte (CPT) score < 7 and Model for End-Stage Liver Disease (MELD) score < 18
- •PegIFN alfa-2a/RBV-naïve or previously treated patients (partial responders, null responders and relapsers)
- •Hepatocellular carcinoma within transplant criteria in the United Network for Organ Sharing (UNOS) Region IV:
- •Single lesion up to 6 cm, or
- •Two or three lesions with largest no greater than 5 cm and the total tumor diameter no greater than 9 cm
- •Listed for liver transplantation
- •Willingness to give written consent and agree to double contraception
排除标准
- •Decompensated cirrhosis
- •Baseline platelet count less than 35,000/µL
- •Baseline hemoglobin level less than 10 g/dL
- •Baseline absolute neutrophil count less than 750/mm3
- •Baseline creatinine clearance < 50 mL per min.
- •Women with a positive pregnancy test at baseline or men whose female partners are pregnant or are contemplating pregnancy
- •Intolerance or contraindications to PegIFN alfa-2a/RBV use per standard treatment guidelines
研究组 & 干预措施
Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir
Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day.
干预措施: Pegylated Interferon Alfa 2a (Drug)
Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir
Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day.
干预措施: Telaprevir (Drug)
Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir
Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant
时间窗: 12 weeks post-transplant, up to 48 weeks for overall monitoring
The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant. Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate.
次要结局
- Sustained Virological Response (SVR)(60 weeks)