EUCTR2012-003280-22-BE进行中（未招募）1 期
Phase 3 open label study evaluating the efficacy and safety of pegylated interferon lambda-1a, in combination with ribavirin and daclatasvir, for treatment of chronic HCV infection with treatment naïve genotypes 1, 2, 3 or 4 in subjects co-infected with HIV.Revised Protocol 01 - Incorporates Administrative Letter 01 and Amendment 02+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific(version 1.0, dated 15-Apr-2013) - DIMENSIO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •HCV Genotype-1, -2, -3 or -4 treatment naïve;
- •Male and females, 18 years of age and above
- •HCV RNA = 10,000 IU/mL at screening;
- •HIV-1 infection (approximately 200 subjects receiving HAART, approximately 100 subjects not receiving HAART);
- •For subjects receiving HAART, HIV RNA must be below < 40 copies/mL at screening and < 200 copies/mL for at least 8 weeks prior to screening;
- •CD4 cell count at screening must be = 100 cells/µL if receiving HAART or = 350 cells/µL if not receiving HAART
- •Seronegative for HBsAg
- •Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2 at screening;
- •Subjects with compensated cirrhosis are permitted, but the number of subjects will be capped at approximately 30%. If a subject does not have cirrhosis, a liver biopsy within 3 years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. Fibroscan® or FibroTest are acceptable if performed within 1 year prior to treatment in countries where liver biopsy is not required prior to treatment and where non-invasive imaging tests are approved for staging of liver disease.
- •Subjects with mild to moderate hemophilia as defined as:
- •- Mild – factor level activity of 6-40% OR
- •- Moderate defined as factor level activity of 1-5%
- •For additional inclusion criteria, please refer to Protocol section 3.3.1
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Any evidence of liver disease other than chronic HCV;
- •Subjects infected with HIV-2;
- •Diagnosed or suspected hepatocellular carcinoma;
- •Decompensated liver disease;
- •Presence of AIDS-defining opportunistic infections within 12 weeks prior to study entry;
- •Laboratory values: ANC < 1.5 x 109 cells/L (< 1.2 x 109 cells/L for Black subjects), platelet count <90 x 109 cells/L, hemoglobin < 11 g/dL for females, hemoglobin < 12 g/dL for males;
- •Subjects (receiving HAART) who had first initiated anti-retroviral therapy within last 8 weeks prior to Day 1; however, if changes are required to a subject’s HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. Subjects should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, < 40 copies/mL;
- •Subjects on zidovudine (AZT), didanosine (ddI), or stavudine (d4T);
- •Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Subjects with severe hemophilia (defined as < 1% factor activity level)
- •For additional exclusion criteria, please refer to Protocol section 3.3.2
研究者
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