NCT00550862终止2 期
A Study of INT 747 (6α-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis
Intercept Pharmaceuticals32 个研究点 分布在 8 个国家目标入组 165 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 165
- 试验地点
- 32
- 主要终点
- Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP)
研究概览
简要总结
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
详细描述
None provided
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 to 70 years.
- •Stable dose of ursodeoxycholic acid (URSO, UDCA) for at least 6 months prior to screening.
- •Female patients must be postmenopausal, surgically sterile, or prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of dosing.
- •Male patients must be prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of the dosing.
- •Proven or likely PBC, as demonstrated by the patient presenting with at least 2 of the following 3 diagnostic factors:
- •History of increased AP levels for at least 6 months prior to Day 0
- •Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)
- •Liver biopsy consistent with PBC.
- •Screening AP value between 1.5 and 10 × ULN.
排除标准
- •Administration of the following drugs at any time during the 3 months prior to screening for the study: colchicine, methotrexate, azathioprine, or systemic corticosteroids.
- •Screening conjugated (direct) bilirubin >2 × ULN.
- •Screening ALT or AST >5 × ULN.
- •Screening serum creatinine >1.5 mg/dL (133 mol/L).
- •History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
- •History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis (NASH).
- •Pregnancy.
研究组 & 干预措施
INT-747 10 mg
Experimental
INT-747 10 mg once daily in combination with URSO for 12 weeks.
干预措施: INT-747 (Drug)
INT-747 10 mg
Experimental
INT-747 10 mg once daily in combination with URSO for 12 weeks.
干预措施: Ursodeoxycholic Acid (URSO) (Drug)
INT-747 25 mg
Experimental
INT-747 25 mg once daily in combination with URSO for 12 weeks.
干预措施: INT-747 (Drug)
INT-747 25 mg
Experimental
INT-747 25 mg once daily in combination with URSO for 12 weeks.
干预措施: Ursodeoxycholic Acid (URSO) (Drug)
INT-747 50 mg
Experimental
INT-747 50 mg once daily in combination with URSO for 12 weeks.
干预措施: INT-747 (Drug)
INT-747 50 mg
Experimental
INT-747 50 mg once daily in combination with URSO for 12 weeks.
干预措施: Ursodeoxycholic Acid (URSO) (Drug)
Placebo
Placebo Comparator
Placebo once daily in combination with URSO for 12 weeks.
干预措施: INT-747 (Drug)
Placebo
Placebo Comparator
Placebo once daily in combination with URSO for 12 weeks.
干预措施: Ursodeoxycholic Acid (URSO) (Drug)
Placebo
Placebo Comparator
Placebo once daily in combination with URSO for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP)
时间窗: Baseline and Up to Day 85
Blood samples were collected for the analysis of serum ALP. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). Percent change from Baseline was calculated as Post Baseline minus Baseline value divided by Baseline value and multiplied by 100.
次要结局
- Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: Osteopontin(Baseline and Up to Day 85)
- LTSE Phase: Mean Percent Change From Baseline in Serum ALP, AST, ALT and GGT Levels(Baseline and at 3, 6, 9 and 12 Months)
- Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels(Baseline and at Days 15, 29, 57 and 85)
- Double-blind Phase: Absolute Values for Albumin Levels(Baseline and at Days 15, 29, 57 and 85)
- Double-blind Phase: Absolute Values for Conjugated (Direct) Bilirubin(Baseline and at Days 15, 29, 57 and 85)
- Double-blind Phase: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score(Baseline and up to Day 85)
- Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: NEFA(Baseline and Up to Day 85)
- Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: TNF-alpha(Baseline and Up to Day 85)
- Double-blind Phase: Percent Change From Baseline in Serum ALP, AST, ALT and GGT Levels(Baseline and at Days 15, 29, 57 and 85)
- Double-blind Phase: Change From Baseline in Total Endogenous Bile Acids(Baseline and Up to Day 85)
- LTSE Phase: Change From Baseline in Quality of Life as Determined by PBC-40 Scale(Baseline and at 6 and 12 months)
- Double-blind Phase: Percent Change From Baseline in Conjugated (Direct) Bilirubin(Baseline and at Days 15, 29, 57 and 85)
- Double-blind Phase: Change From Baseline in Quality of Life (QoL) as Determined by Primary Biliary Cirrhosis 40 (PBC-40) Scale(Baseline and at Days 29, 57 and 85)
- Double-blind Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to Day 85)
- Double-blind Phase: Change From Baseline in Pruritus Visual Analog Scale (VAS)(Baseline and at Days 29, 57 and 85)
- Double-blind Phase: Absolute Values for Fibroblast Growth Factor 19 (FGF19)(Baseline and Up to Day 85)
- Double-blind Phase: Percent Change From Baseline Values for FGF19(Baseline and Up to Day 85)
- Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: Non-essential Fatty Acid (NEFA)(Baseline and Up to Day 85)
- Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: C-reactive Protein(Baseline and Up to Day 85)
- Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: Tumor Necrosis Factor Alpha (TNF-alpha)(Baseline and Up to Day 85)
- Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: TNF-beta and Tumor Growth Factor Beta (TGF-beta)(Baseline and Up to Day 85)
- Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: Bile Acids and Glutathion(Baseline and Up to Day 85)
- Double-blind Phase: Change From Baseline to Day 85 in Quality of Life as Determined by Short Form-36 (SF-36) Scale(Baseline and Up to Day 85)
- Double-blind Phase: Change From Baseline in Quality of Life as Determined by 5-Dimension (5-D) Domain Scale(Baseline and at Days 29, 57 and 85)
- LTSE Phase: Number of Participants With TEAEs and SAEs(Up to 12 Months)
- LTSE Phase: Absolute Values of Quality of Life as Determined by SF-36 Scale(Baseline and at 3, 6, 9 and 12 Months)
- Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: TNF-beta and TGF-beta(Baseline and Up to Day 85)
- Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: Osteopontin(Baseline and Up to Day 85)
- Double-blind Phase: Absolute Values for Total Endogenous Bile Acids(Baseline and Up to Day 85)
- Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: Bile Acids and Glutathion(Baseline and Up to Day 85)
- Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: Immunoglobulin M (IgM)(Baseline and Up to Day 85)
- Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: IgM(Baseline and Up to Day 85)
- Double-blind Phase: Percent Change From Baseline in Albumin Levels(Baseline and at Days 15, 29, 57 and 85)
- LTSE Phase: Mean Percent Change From Baseline in Total and Conjugated (Direct) Bilirubin(Baseline and at 3, 6, 9 and 12 Months)
- Double-blind Phase: Change From Baseline in HA, P3NP, and TIMP-1 Levels(Baseline and Up to Day 85)
- Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: C-reactive Protein(Baseline and Up to Day 85)
研究者
研究点 (32)
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