NCT01200420已完成2 期
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (Miravirsen) Administered to Treatment-Naïve Subjects With Chronic Hepatitis C (CHC) Infection
Santaris Pharma A/S7 个研究点 分布在 6 个国家目标入组 38 人开始时间: 2010年9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
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- Safety and tolerability
研究概览
简要总结
The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C.
Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.
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
- •BMI 18-38 kg/m2
- •Treatment-naïve to interferon-alpha based therapies
- •HCV genotype 1
- •Clinical and laboratory findings consistent with a clinical diagnosis of CHC, including:
- •Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment, OR Positive HCV serology (HCV antibody or HCV RNA) with a prior remote risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C
- •Serum HCV RNA > 75,000 IU/mL at Screening
- •(North American sites only). Liver biopsy within 36 months of Day 1, indicating the absence of cirrhosis
- •Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met:
- •Platelets >100,000/mm3
- •Total WBC > 3000/mm3 and ANC >1500/mm3
- •Hemoglobin > 11 g/dL for females and > 12 g/dL for males
- •Total and direct bilirubin, WNL (except for clearly documented Gilbert's Syndrome)
- •ALT < 5 x ULN
- •Serum creatinine WNL and creatinine clearance as calculated by the Cockcroft-Gault formula > 80 ml/min
- •Negative results on the following Screening laboratory tests: urine or serum pregnancy test (for women of childbearing potential), hepatitis B surface antigen and human immunodeficiency virus (HIV) antibody.
- •For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to Screening). IUD, Depo-Provera, Norplant System implants, bilateral tubal ligation, vasectomy, condom or diaphragm plus either contraceptive sponge, foam or jelly and abstinence.
排除标准
- •Other known cause of liver disease except for CHC
- •History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding, fibrosis or other signs of hepatic insufficiency or portal hypertension
- •History of hepatocellular carcinoma (HCC) on imaging studies or serum alpha-fetoprotein (AFP) > 50 ng/mL at Screening
- •Concurrent clinically significant medical diagnosis (other than hepatitis C-related conditions) that would potentially interfere with the subjects study compliance or confound study results
- •Concurrent social conditions (e.g. drugs, alcohol, transportation) which would potentially interfere with the subject's study compliance
- •Clinically significant illness within 30 days preceding entry into the study
- •Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication.
研究组 & 干预措施
miravirsen
Experimental
Dose escalation study with review of safety data following each cohort.
干预措施: miravirsen (Drug)
saline
Placebo Comparator
Dose escalation study with review of safety data following each cohort.
干预措施: saline (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: regularly over 18 weeks
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, 12 lead and ECG monitoring.
次要结局
- Pharmacokinetics(continuously over 4 weeks)
- Miravirsen treatment effect on viral titer(regularly over 18 weeks)
研究者
研究点 (7)
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