EUCTR2009-011182-86-BG进行中（未招募）不适用
480 Study: Phase 2b Open-label, Randomized Study in Treatment Naïve Subjects with HCV Genotype 1 to Compare the Efficacy, Safety, and Tolerability of the 480 µg Dose of Locteron™ Plus Ribavirin Given Bi-Weekly to 1.5 µg /kg PEG-Intron™ Plus Ribavirin Given Weekly
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Willing and able to provide written informed consent
- •Male and female subjects 18 through 69 years of age, inclusive
- •Chronic hepatitis C genotype 1
- •HCV ribonucleic acid (RNA) level > 10,000 IU/mL (by RT-PCR) at screening
- •Creatine clearance more than or equal to 50 mL/min
- •Neutrophil count > 1500 cells/mm3
- •Platelet count > 90,000/mm3
- •Hemoglobin > 12 g/dL for females and > 13 g/dL for males
- •Female subjects of child-bearing potential agreeing to use dual methods for contraception (oral or parenteral contraceptive drugs + barrier method) for the duration of the study and up to 24 weeks after stopping study drug
- •Male subjects with female sexual partners agreeing to use effective birth control methods for the total duration of the study and up to 28 weeks after stopping study drug
- •Negative serum pregnancy test for women of child-bearing potential at screening and confirmed by negative urine pregnancy test within the 24-hour period prior to the first dose of study drug
- •Compensated liver disease defined as INR < 1.5, conjugated bilirubin < 1.5 ULN, serum albumin > 3.0 g/dL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior antiviral treatment for hepatitis C (defined as more than one dose of interferon based therapy and any administration of a targeted antiviral therapy)
- •Co-infection with HIV or hepatitis B virus (HBsAg positive), acute hepatitis A (HAV IgM positive)
- •Subjects with a body mass index (BMI) above 32 kg/m2
- •Current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage)
- •Evidence of HCC; for example, alfa-fetoprotein more than 50 ng/mL or by any other standard of care measure
- •Uncontrolled diabetes mellitus as evidenced by HbA1C = 8.5% at screening
- •Known hypersensitivity to interferon alfa or ribavirin, or with any other contraindications to these medications, e.g. after use of these agents for non-hepatitis C disorders
- •Chronic liver disease other than HCV not limited to HBV, hemochromatosis, auto-immune hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease
- •Clinically significant hemoglobinopathy such as thalassemia major and sickle cell anemia
- •History of moderate, severe or uncontrolled psychiatric disease including depression and prior suicide attempts
- •History of immune-mediated disease (e.g., inflammatory bowel disease, immune thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, moderate to severe psoriasis, rheumatoid arthritis, antinuclear antibody (ANA) titer more than or equal to 1:640 at screening)
- •Significant renal or neurological disease
- •Severe degree (> GOLD stage III) of chronic pulmonary disease (COPD) or active, severe asthma
- •Subjects with severe cardiac disease (e.g., heart failure, recent [i.e., within 6 months prior to first dosing] myocardial infarction, angina, serious arrhythmias, including prolonged QTc [> 450 mSec], uncontrolled hypertension)
- •History of significant central nervous system (including CNS trauma) or seizure disorders
- •Cancer within the last 5 years, or previous cancer with a high risk of recurrence, including metastatic breast cancer; non-melanoma skin cancer is not an exclusion criterion
- •History of solid organ or bone marrow transplantation
- •Clinical or laboratory evidence of uncontrolled thyroid disease, e.g., by thyroid stimulating hormone (TSH) level > 1.2 x upper limit of normal
- •Clinically significant retinopathy; this needs to have been excluded by an eye exam performed by an ophthalmologist within the last 6 months prior to screening for subjects with hypertension or diabetes mellitus
- •Drug abuse or alcohol consumption within the last 6 months which, in the opinion of the investigator, may affect study participation or outcome. Subjects in a supervised methadone treatment program on a stable regimen for > 6 months may be considered
- •Taken any experimental agent within 12 weeks prior to screening
- •More than 30 days of systemic immunosuppressive medication to include steroids in doses equivalent to or greater than 10 mg prednisone per day within 30 days prior to screening (inhaled corticosteroids are allowed)
- •Nursing mother or male partner of pregnant female.
研究者
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