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临床试验/NCT03163849
NCT03163849Unknown3 期

Assessment of Haematological and Biochemical Effect After New Direct Acting Antiviral Drugs in Chronic Hepatitis c Virus Egyptian Patients in Assiut Province

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
50
试验地点
1
主要终点
the percentage of patients with hematological changes

研究概览

简要总结

Chronic hepatitis C virus infection affects an estimated one hundred and seventy million people around the world with and approximate prevalence 0.2-2 % in the United State of America and European countries.

详细描述

In Egypt, Chronic hepatitis C virus is a serious health problem where Chronic hepatitis C virus prevalence is very high.

Chronic Chronic hepatitis C virus infection is associated with a high risk for liver-related mortality because of a variety of complications, which appear obviously in those patients with developing end-stage liver disease, including decompensated liver cirrhosis and hepatocellular carcinoma. Egypt had the highest burden of deaths from Chronic hepatitis C virus-associated hepatocellular carcinoma in the Arab world, around sixty three percentage of all Chronic hepatitis C virus-associated hepatocellular carcinoma deaths happened in Egypt.

Poor response rates and poor tolerability were observed during treatment of chronic Chronic hepatitis C virus infection with pegylated interferon and ribavirin.

Because Chronic hepatitis C virus does not incorporate into the human genome and must replicate to maintain infection, it should be potential to destroy the virus completely by blocking replication at one or more stages of the life cycle.

In recent years, there has been a shift in treatment paradigm with the discovery and approval of agents that target specific proteins vital for hepatitis C replication. The Non Structural 3/4A inhibitors simeprevir and paritaprevir, the NonStructural 5A inhibitors ombitasvir, ledipasvir, and daclatasvir, and the Non Structural 5B inhibitors sofosbuvir and dasabuvir have been approved and incorporated as first-line agents into the latest guidelines for Hepatitis C treatment. Used in combination, these agents produce higher rates of sustained virologic response and less adverse effects than historical options, along with limited rates of resistance.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Our study proposed for all consented patients complaining from chronic Hepatitis C virus infection undergoing treatment with antiviral drugs is possible through certain indications or criteria as follow:
  • Patients with chronic Hepatitis C virus who are candidates for Direct Acting Antiviral Therapy:
  • Age is from 18 to 65 years.

排除标准

  • Those patients with chronic Hepatitis C virus infection are impossible or contraindicated to be treated with antiviral drugs as follow: - Geriatrics (> 65 years of age): - Pediatrics (< 18 years of age): - patients with known hypersensitivity to any of the components of the antiviral drug.
  • Post-Liver Transplant Patients. ـPatients with primary haematological abnormalities not related to chronic hepatitis C virus infection
  • Experienced patients (previously failed treatment)

研究组 & 干预措施

control group

Placebo Comparator

oral tablets

干预措施: Placebos (Drug)

Study group

Experimental

sofosbuvir , daclatasvir oral tablets

干预措施: Sofosbuvir , daclatasvir (Drug)

结局指标

主要结局

the percentage of patients with hematological changes

时间窗: 12 weeks

complete blood count and prothrombin time and concentration

The percentage of patients with antibodies against RBCs

时间窗: Pre treatment

Coomb's test

次要结局

  • the percentage of patients with biochemical changes(12 weeks)
  • The percentage of patients with antibodies against RBCs(Three months after the end of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sahar Ezeldeen Hussein Ali

Principal investigator

Assiut University

研究点 (1)

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