A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-04136309 500 MG BID IN SUBJECTS WITH CHRONIC HCV INFECTION AND RAISED AMINOTRANSFERASES
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 10
- 主要终点
- Percentage of Participants With a Response in Serum Alanine Aminotransferase (ALT) Level at Week 4
研究概览
简要总结
This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus infection and abnormal liver enzymes.
详细描述
Study recruitment was stopped on Dec 15, 2011 due to difficulty in enrolling the targeted number of patients. Subjects currently enrolled into the study will complete the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The new anticipated Last Subject Last Visit (LSLV) is February 2012.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV infection
- •ALT >1.5 but <10 times upper limit of normal
排除标准
- •Decompensated or severe liver disease defined by one or more of the following criteria:
- •Prior liver biopsy showing cirrhosis.
- •International Normalized Ratio (INR) greater than or equal to 1.
- •Total bilirubin greater than or equal to 1.5X ULN, or >2X ULN for unconjugated bilirubin.
- •Serum albumin below normal.
- •ALT or aspartate aminotransferase (AST) >10 x ULN.
- •Evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.
- •Presence of human immunodeficiency virus (HIV).
- •Co-infection with hepatitis B virus (HBV).
- •Co-infection with Epstein Barr Virus (EBV) and/or Cytomegalovirus (CMV).
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
PF-04136309
干预措施: PF-04136309 (Drug)
结局指标
主要结局
Percentage of Participants With a Response in Serum Alanine Aminotransferase (ALT) Level at Week 4
时间窗: Week 4
Responder was defined as a participant who experienced reduction in ALT of greater than or equal to (\>=) 30 percent (%) of the baseline value. Baseline ALT value was defined as mean of measurements collected at screening visits 1 and 2 and pre-dose Day 1. ALT levels were determined at central lab.
次要结局
- Percentage of Participants With a Response in Serum Aspartate Aminotransferase (AST) Level From Baseline at Week 4(Week 4)
- Change From Baseline in Serum ALT at Weeks 1, 2, 3 and 4(Baseline, Weeks 1, 2, 3 and 4)
- Serum ALT at Baseline(Baseline)
- Change From Baseline in Serum AST at Weeks 1, 2, 3 and 4(Baseline, Weeks 1, 2, 3 and 4)
- Serum AST at Baseline(Baseline)
- Change From Baseline in Methacetin Breath Test (BreathID) at Weeks 1 and 4(Baseline, Weeks 1 and 4)
- Change From Baseline in Enhanced Liver Fibrosis Test (ELF) at Week 4(Baseline, Week 4)
- Maximum Observed Plasma Concentration (Cmax) of PF-04136309(Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28)
- Plasma Decay Half-Life (t1/2) of PF-04136309(Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28)
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04136309(Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04136309(Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28)
- Change From Baseline in Phosphorylated Extracellular Signal- Regulated Kinase (p-ERK) Levels at Week 2 and 4(Baseline, Week 2 and 4)
- Baseline p-ERK(Baseline)