NCT02762383终止3 期
A Pilot, Open-Label, Multicentre Study Evaluating the Long-Term Safety and Tolerability of a Low-Dose Peginterferon Alfa-2a Maintenance Monotherapy in Chronic Hepatitis C Patients Co-Infected With Human Immunodeficiency Virus and Who Do Not Respond to a Standard Regimen of Peginterferon Alfa-2a Plus Ribavirin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 19
- 主要终点
- Percentage of Participants with Adverse Events (AEs)
研究概览
简要总结
This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA) after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety and tolerability. Secondary objectives are to evaluate histological, virological, and biochemical effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serologic evidence of chronic hepatitis C infection by anti-HCV antibody test
- •Received peginterferon alfa-2a for at least 12 weeks and either did not reach a 2-log drop in HCV RNA after 12 weeks of treatment, did not reach an undetectable HCV RNA after 24 weeks of treatment, or reached undetectable HCV RNA that was detectable again at the end of 48 weeks of treatment
- •Detectable serum HCV RNA at Screening
- •Serologic evidence of HIV infection by HIV RNA detection
- •CD4 cell count greater than or equal to (>/=) 100 cells/mcL during therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
- •Stable HIV status and, if on antiretroviral therapy, a stable regimen for at least 6 weeks prior to Baseline
- •Compensated liver disease
- •No evidence of hepatocellular carcinoma
排除标准
- •Pregnant or breastfeeding
- •Antineoplastic or immunomodulatory treatment within 6 months prior to first dose
- •Any investigational drug within 6 weeks prior to first dose
- •Positive for hepatitis A immunoglobulin M antibody
- •Severe neutropenia or thrombocytopenia at Screening while still on therapy with peginterferon alfa-2a plus ribavirin
- •Severe psychiatric or neurologic comorbidity
- •History of any significant medical conditions, such as immune disorders or disease of the major organ systems
- •Uncontrolled thyroid disease
- •Severe retinopathy
- •Evidence of drug abuse
研究组 & 干预措施
Peginterferon Alfa-2a
Experimental
Participants will receive a low dose of peginterferon alfa-2a for 18 months.
干预措施: Peginterferon Alfa-2 (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events (AEs)
时间窗: From Baseline to end of treatment (up to 18 months)
次要结局
- Percentage of Participants with Histological Response According to Paired Biopsy(At end of treatment (up to 18 months))
- Cluster of Differentiation (CD) 4 Cell Count in Cells per Microliter (cells/mcL)(At end of treatment (up to 18 months))
- Percentage of Participants with Virological Response According to HCV RNA Viral Load(At 6, 12, and 18 months during treatment, and at 24 weeks after end of treatment (up to 2 years overall))
- HIV RNA Viral Load in Copies per Milliliter (copies/mL)(At end of treatment (up to 18 months))
- Percentage of Participants with Biochemical Response According to Alanine Aminotransferase (ALT) Level(At end of treatment (up to 18 months))
- Percentage of Participants with Sustained Biochemical Response According to ALT Level(At 24 weeks after end of treatment (up to 2 years overall))
研究者
相似试验
已完成
4 期
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.Hepatitis B, ChronicNCT01519921Hoffmann-La Roche150
已完成
3 期
A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant PhasePediatric Immuno-Tolerant Chronic Hepatitis BNCT02263079Hoffmann-La Roche62
已完成
4 期
A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis BHepatitis B, ChronicNCT02598063Hoffmann-La Roche255
Unknown
3 期
HRN 004- Peginterferon a-2a Plus Ribavirin for Chronic Hepatitis C Infection in HIV Infected Persons Who Have Failed to Achieve a Sustained Virologic Response Following Previous Interferon TherapyChronic Hepatitis C Infection in HIV Infected PersonsHIV InfectionsNCT00215839Hepatitis Resource Network
已完成
4 期
A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)Hepatitis C, ChronicNCT01447420Hoffmann-La Roche129