Open Label Phase 2 Clinical Study of Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The goal of this study is to assess the therapeutic response to 48 weeks of treatment with peginterferon lambda and lonafarnib boosted with ritonavir in patients with chronic hepatitis D.
研究概览
简要总结
Background:
Chronic hepatitis D is a serious liver disease caused by a virus. Currently, no medications are approved to treat chronic hepatitis D.
Objective:
To test a combination of 3 drugs in people with chronic hepatitis D.
Eligibility:
People 18 years or older with chronic hepatitis D.
Design:
Participants will be in the study about 2 years. They will have 3 inpatient stays of 3 to 5 days.
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function and an ultrasound: a wand that uses sound waves to create images of the liver will be rubbed over the skin on their torso.
Participants will stay in the clinic for a 3-day baseline visit. They will have imaging scans, an eye exam, and a visit with a reproductive specialist. They will have a liver biopsy: about 1 inch of liver tissue will be removed, either with a tube inserted through a vein in the neck, or with a needle inserted through the participant s side.
Participants will take the study drugs for 48 weeks. Two of them are tablets taken twice a day at home; 1 is a shot administered once a week. Participants will begin taking the drugs during a 5-day stay in the clinic. Then they will have 15 outpatient visits while taking the drugs and 7 more after they finish.
The last 3-day clinic stay will be 6 months after participants finish taking the drugs. The liver biopsy, imaging scans, and other tests will be repeated.
详细描述
Study Description:
This is an open-label clinical trial treating 30 adult patients with chronic delta hepatitis with peginterferon lambda and lonafarnib boosted with ritonavir for 48 weeks. This is a follow up study to the previous 24-week combination study we had previously completed which demonstrated promising results. We hypothesize that therapy with peginterferon lambda and lonafarnib boosted with ritonavir will lead to a significant decline in hepatitis D virus RNA levels.
Objectives:
Primary Objective:
The goal of this study is to assess the therapeutic response to 48 weeks of treatment with peginterferon lambda and lonafarnib boosted with ritonavir in patients with chronic hepatitis D.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Peginterferon Lambda
A weekly subcutaneous injection of peginterferon lambda at a dose of 180 mcg and an oral twice daily dosing of Lonafarnib at 50mg boosted with twice daily Ritonavir at 100mg for 48 weeks. Following 48 weeks of treatment the subjects will be monitored for outcomes during an additional 6-month time period.
干预措施: Peginterferon Lambda (Drug)
结局指标
主要结局
The goal of this study is to assess the therapeutic response to 48 weeks of treatment with peginterferon lambda and lonafarnib boosted with ritonavir in patients with chronic hepatitis D.
时间窗: 48 weeks
This is a phase 2 study evaluating the efficacy and safety of a novel regimen for the treatment of chronic HDV infection.
次要结局
未报告次要终点