NL-OMON34513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 - SPC3649 multiple-dose study
Santaris Pharma A/S0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female, age 18 to 65 years, inclusive
- •2. BMI 18-38 kg/m2
- •3. Treatment-naïve to interferon-alpha based therapies
- •4. HCV genotype 1
- •5. Clinical and laboratory findings consistent with a clinical diagnosis of Chronic Hepatitis C (CHC), including:
- •a. Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment,
- •b. 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
- •6. Serum HCV RNA > 75,000 IU/mL at Screening
- •7. Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met:
- •a. Platelets >100,000/mm3
- •b. Total WBC > 3000/mm3 and ANC >1500/mm3
- •c. Hemoglobin > 11 g/dL for females and > 12 g/dL for males
- •d. Total and direct bilirubin, WNL (except for clearly documented Gilbert*s Syndrome)
- •e. ALT < 3 x ULN
- •f. Serum creatinine WNL and estimated creatinine clearance rate as calculated by the Cockcroft-Gault formula > 80 ml/min
- •8. 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.
- •9. 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.
- •For female study participants, adequate birth control methods will be defined as: intrauterine device or double barrier contraception, i.e., condom plus diaphragm, condom or diaphragm plus spermicidal gel /foam.
- •For males study participants, adequate birth control methods will be defined as: double barrier contraception, i.e., condom plus diaphragm; condom or diaphragm plus spermicidal gel/foam. ;Note: Females who are not of childbearing potential must meet one of the following criteria:
- •Post-menopause - defined as one year without menses or follicle-stimulating hormone (FSH) of >40 U/mL
- •Surgical menopause - hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
排除标准
- •Subjects who meet any of the following criteria at Screening are not eligible to participate in this study:
- •1. Other known cause of liver disease except for CHC
- •2. 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
- •3. History of hepatocellular carcinoma (HCC) on imaging studies or serum alpha-fetoprotein (AFP) > 50 ng/mL at Screening
- •4. Concurrent clinically significant medical diagnosis (other than hepatitis C-related conditions) that would potentially interfere with the subjects study compliance or confound study results
- •5. Concurrent social conditions (e.g. drugs, alcohol, transportation) which would potentially interfere with the subject*s study compliance
- •6. Clinically significant illness within 30 days preceding entry into the study
- •7. Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication.
研究者
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