A Phase 2, Randomized, Placebo Controlled, Dose Ranging Study To Evaluate Peginterferon Alfa 2a (Pegasys®) And Ribavirin (Copegus®) With And Without PF-00868554 In Subjects Chronically Infected With Hepatitis C Virus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set
研究概览
简要总结
The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment naive (no prior treatment with IFN-a +/- RBV regimens.
- •Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.
- •HCV RNA > 100,000 IU/mL at screening.
- •A diagnosis of chronic HCV infection for at least 6 months.
排除标准
- •Evidence of acute or chronic infection with HIV or HBV.
- •Exposure within the previous three months to an investigational anti-HCV agent.
- •Evidence of severe or decompensated liver disease.
- •Subjects with liver disease unrelated to HCV infection.
研究组 & 干预措施
A
500 mg BID
干预措施: PF-00868554 (Drug)
B
300 mg BID
干预措施: PF-00868554 (Drug)
C
200 mg BID
干预措施: PF-00868554 (Drug)
D
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set
时间窗: Baseline, Week 4
Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter \[IU/mL\]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set
时间窗: Baseline, Week 4
Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
次要结局
- Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)(Week 4, 12, 48, 60, 72)
- Alanine Aminotransferase (ALT) Levels(Week 4, 12, 48, 72)
- Population Pharmacokinetics (PK) of PF-00868554(1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28)