NCT02558114终止4 期
Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Sustained virological response measured by HEV RNA
研究概览
简要总结
The purpose of the study is to compare the efficacy, safety and recurrence rate of two therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the viremia within 4 weeks of the start of treatment (12 vs 24 weeks).
The purpose of the study is also improve the safety of treatment with Ribavirin by optimizing dose adjusted to renal function, plasma levels of drug and hemoglobin.
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
- 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
- •Age equal or greater than 18 years.
- •To comply with any of the following diagnoses:
- •chronic Hepatitis E: HEV RNA detectable in patients with elevated transaminase levels for at least 6 months and / or HEV RNA detectable in two separated determinations by an interval of six months .
- •severe acute Hepatitis E: alanine aminotransferase (ALT) levels greater than 10 times the normal limit, with HEV RNA positive, and signs of acute liver injury (International normalized ratio(INR> 1.5)); or with extrahepatic manifestations or liver failure in patients with previous liver disease.
- •Signed informed consent
排除标准
- •Terminal illness with a expected life expectancy of less than 6 months
- •Patients with contraindications for treatment with Ribavirin:
- •pregnancy or lactation.
- •Severe hepatic impairment or decompensated cirrhosis.
- •hemoglobinopathies (thalassemia, sickle cell anemia).
- •history of severe pre-existing cardiac disease, including unstable heart disease.
研究组 & 干预措施
Group A
Other
Patients will receive ribavirin during 12 weeks
干预措施: Ribavirin (Drug)
Group B
Other
Patients will receive:
- ribavirin during 12 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is undetectable at week 4 after treatment start (adjust to renal function)
-
- ribavirin during 24 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is detectable at week 4 after treatment start (adjust to renal function)
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained virological response measured by HEV RNA
时间窗: 48 weeks
HEV RNA undetectable at 48 weeks after end of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Comparison of Therapy in Treatment of Patients With Helicobacter Pylori Infection: Concomitant Versus Hybrid Therapy.Helicobacter Pylori InfectionNCT03572777Antonio Mestrovic159
终止
4 期
A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated AppendicitisAppendicitisNCT00236912Johnson & Johnson Pharmaceutical Research & Development, L.L.C.139
终止
不适用
Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.Lateral EpicondylitisTennis ElbowPosterolateral Rotator InstabilityNCT03234192NYU Langone Health21
Unknown
4 期
PC-Trial: Patent Foramen Ovale and Cryptogenic EmbolismEmbolism, ParadoxicalHeart Septal Defects, AtrialNCT00166257Foundation for Cardiovascular Research, Zurich414
Unknown
不适用
Morton's Neuroma: Manipulation Versus Steroid InjectionNeuroma, Human ForefootNCT02304094Queen Margaret University64