A Phase 2a Trial to Evaluate the Safety, Tolerability, and Efficacy of 12 Weeks of Sovaprevir, ACH-0143102 and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotype-1 Viral Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment
研究概览
简要总结
The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with sovaprevir, ACH-0143102, and ribavirin (RBV) in genotype-1 (GT-1), treatment-naive, hepatitis C virus (HCV) participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV infection.
- •HCV ribonucleic acid > 10,000 international units/milliliter at screening.
- •Female participants must be willing to use 2 effective methods of contraception, one of which must be a barrier method, during the dosing period and 6 months after the last dose of RBV. Females of childbearing potential must have a negative pregnancy test at screening and baseline.
- •Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months.
- •Signed and dated written informed consent form.
- •Willing to participate in all study activities and all study requirements (including effective contraception) during the study period.
- •Treatment-naïve participants were defined as those participants who have never received pegylated interferon, RBV, or a direct-acting anti-viral agent for the treatment of chronic HCV infection.
- •A liver biopsy within the last 3 years without evidence of cirrhosis.
排除标准
- •Body mass index > 36.0 kilograms/meter squared.
- •Pregnant or nursing (lactating) female participants confirmed by a positive human chorionic gonadotropin laboratory test or contemplating pregnancy.
- •Participation in any interventional clinical trial within 35 days prior to first study medication dose administration on Day
- •Known human immunodeficiency virus (HIV)-1 or HIV-2 infection/serology and/or positive hepatitis B surface antigen.
- •Use of dietary supplements, grapefruit juice, herbal supplements, cytochrome P450 (CYP) 2C8 substrates, CYP3A4 inducers and inhibitors, P-glycoprotein inducers and substrates, organic-anion-transporting polypeptide inhibitors and substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing through 7 days following completion of study medications.
- •Clinically significant laboratory abnormality at screening (specified in protocol).
- •Other forms of liver disease.
- •History of severe or uncontrolled psychiatric disease.
- •History of malignancy of any organ system, treated or untreated within the past 5 years.
- •History of major organ transplantation.
- •Use of bone marrow colony stimulating factor agents within 3 months prior to baseline.
- •History of seizure disorder requiring ongoing medical therapy.
- •History of known coagulopathy including hemophilia.
- •History of hemoglobinopathy, including sickle cell anemia and thalassemia.
- •History of immunologically mediated disease (specified in protocol).
- •History of clinical evidence of significant chronic cardiac disease ( specified in protocol).
- •Electrocardiogram with any clinically significant abnormality.
- •Structural or functional cardiac abnormalities (specified in protocol).
- •History of chronic obstructive pulmonary disease, emphysema, or other chronic lung disease.
- •Participants currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol abuse in the judgement of the investigator.
研究组 & 干预措施
Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
干预措施: Sovaprevir (Drug)
Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
干预措施: ACH-3102 (Drug)
Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
干预措施: Ribavirin (Drug)
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
干预措施: Sovaprevir (Drug)
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
干预措施: ACH-3102 (Drug)
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
干预措施: Ribavirin (Drug)
Placebo
Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment
时间窗: Four weeks after the completion of treatment
Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo.
Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants
时间窗: 12 weeks
To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs).
次要结局
未报告次要终点