A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic HCV GT1, GT4 and GT6 Infection With Inherited Blood Disorders With and Without HIV Co-Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 159
- 主要终点
- Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)
研究概览
简要总结
This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%.
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
- Double (Participant, Investigator)
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
- •has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease
- •has cirrhosis or is non-cirrhotic
- •is human immunodeficiency virus (HIV) coinfected or not infected with HIV
- •is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception
排除标准
- •has evidence of decompensated liver disease
- •is coinfected with hepatitis B
- •has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- •has hepatocellular carcinoma (HCC) or is under evaluation for HCC
- •has clinically-relevant drug or alcohol abuse within 12 months of screening
研究组 & 干预措施
Immediate Treatment
Participants will take grazoprevir 100 mg + elbasvir 50 mg once daily during the 12-week treatment period and then will be monitored for safety during a 24-week follow-up period.
干预措施: Grazoprevir + Elbasvir (Drug)
Deferred Treatment
Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period.
干预措施: Grazoprevir + Elbasvir (Drug)
Deferred Treatment
Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)
时间窗: Up to Week 12
An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants Experiencing an Adverse Event (AE)
时间窗: Up to Week 14
An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
时间窗: 12 weeks after completing study therapy (Week 24)
The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid \[RNA\] level below the lower limit of quantification \[LLoQ\] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of \<15 IU/mL.
次要结局
- Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)(24 weeks after completing study therapy (Week 36))