Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.
研究概览
简要总结
This study will provide chronic hepatitis C patients with low platelets (less than 75x10^9/L) the opportunity to undergo treatment and possible cure of their virus. The main hepatitis C drugs will be administered as standard of care, with the addition of the study drug eltrombopag.
The investigators hypothesize that providing eltrombopag to chronic hepatitis C patients with low platelets (less than 75x10^9/L) will permit the initiation and completion of antiviral triple therapy with boceprevir, ribavirin, and pegylated-interferon.
详细描述
SQUELCH-C is an investigator-initiated, single arm, non-blinded pilot study on the use of eltrombopag in combination with ribavirin, pegylated-interferon, and boceprevir, for patients who would not otherwise be treatment candidates because of low platelet counts (less than 75x10^9/L).
Administration of the drugs ribavirin and boceprevir will be standard of care, with one exception for interferon.
The total drug treatment period for the study patient will range from 32 - 56 weeks, depending on liver disease stage and viral response. Follow-up will take place at 12 and 24 weeks post treatment to evaluate for sustained viral response. Total study participation may require 1.5 years.
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
- •Male and female patients at least 18 years of age.
- •Require a platelet count below 75 x 10^9 /L at time of screening.
- •The patients must meet the eligibility criteria for all drugs involved.
- •Only genotype 1 (a, b, indeterminate, or mixed).
- •Confirmed history of chronic hepatitis C.
- •Cirrhotic patients will be included.
- •Liver imaging within 1 year to exclude hepatocellular carcinoma (HCC) is required in patients with cirrhosis.
- •Patients without evidence of cirrhosis but meeting platelet criteria will also be admitted to study.
- •Subjects must be able to provide informed consent, comply with drug administration instructions, and be able to complete each study visit.
- •Ability to cover costs of ribavirin, interferon, and boceprevir will also be required.
- •Female subjects are eligible if: Non-pregnant, non-childbearing potential, or of childbearing potential and willing to perform complete abstinence or correctly use a form of birth control during intercourse [barrier method, intrauterine device, hormonal therapy, or surgical sterilization in females or male partner]. They must also be willing to have pregnancy tests performed every 4- weeks until 6 months after completion of ribavirin.
- •Male study participants must agree to use a condom and their female partner must partake in one of the contraceptive methods discussed above until 6 months after completion of ribavirin therapy.
排除标准
- •A history of chronic infection (i.e., HIV or HBV) or a previous organ transplantation.
- •A history of a platelet disorder.
- •A poorly controlled underlying medical illness (i.e., diabetes, hypertension, coronary artery disease, congestive heart failure, etc.).
- •Any contraindication to any study drugs as mentioned in their respective prescribing information.
- •Patients with decompensated cirrhosis defined as current evidence for ascites, encephalopathy, infection or variceal bleeding. All patients should be considered Child-Pugh Class A.
- •Patients with aminotransferase levels ≥ 500 IU/L will be excluded on presumption of another active liver disease.
- •Patients must not be pregnant or nursing.
- •The study physician maintains the right to exclude a patient for a medical condition not listed above or based off laboratory values indicating chronic disease discovered at screening.
- •Patients with eye disease may be excluded from this study if the ophthalmologist does not recommend treatment.
- •Subjects with known hypersensitivity reactions (such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin) to study drugs or any component of the products.
- •Subjects with autoimmune hepatitis, hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), creatinine clearance less than 50 mL/min.
- •Co-administration of drugs that are highly dependent on CYP3A4/5 for clearance and CYP3A4/5 inducers (See Table 2 in boceprevir prescribing information).
研究组 & 干预措施
Thrombocytopenic (Low Platelet) Patients
All study patients will undergo intervention in this study.
The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).
干预措施: Eltrombopag (Drug)
结局指标
主要结局
Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.
时间窗: Up to 56 weeks
The length of therapy will depend on several factors: 1. Study patient's liver disease status. 2. Study patient's antiviral response. 3. Study patient's tolerance to treatment. One patient completed therapy and experienced a sustained viral response. A minimum full course of treatment will be 30 weeks, with a maximum of 56 weeks of treatment.
次要结局
未报告次要终点