Evaluation of the Role of Rifaximin on Thrombocytopenia in Patients With Hepatitis C-Related Liver Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Impact of Rifaximin treatment for four weeks on platelet count
研究概览
简要总结
Cirrhosis is a common complication of chronic hepatitis C virus (HCV) infection in Egypt. Thrombocytopenia (TP) is the most common cytopenia in patients with cirrhosis and may be associated with variceal bleeding, rebleeding, morbidity, and mortality. Although TP has traditionally been attributed to portal hypertension and splenic sequestration, other mechanisms include impaired thrombopoietin activity, bone marrow suppression, and increased platelet destruction.
Rifaximin is a poorly absorbed, broad-spectrum intestinal antimicrobial agent widely used in patients with cirrhosis, particularly for hepatic encephalopathy. Its minimal systemic absorption limits systemic adverse effects. Rifaximin may reduce intestinal bacterial overgrowth and bacterial translocation, thereby decreasing circulating endotoxin and proinflammatory cytokines that may contribute to haematological abnormalities in cirrhosis.
Previous observations have suggested that intestinal decontamination with rifaximin may increase platelet counts in patients with cirrhosis and thrombocytopenia. This randomised controlled trial was designed to investigate whether rifaximin treatment could improve platelet count in patients with HCV-related liver cirrhosis and thrombocytopenia.
详细描述
After approval by the Ethics Committee of the Faculty of Medicine, Fayoum University, patients were recruited from two tertiary university hospitals in Egypt. Written informed consent was obtained from all patients before enrolment. This was a double-blind, randomised controlled clinical trial that included 165 adults aged 18-75 years with HCV-related liver cirrhosis and thrombocytopenia who had previously received treatment for HCV and achieved a sustained virologic response.
Cirrhosis was diagnosed based on clinical findings (splenomegaly, ascites, and/or esophageal varices), laboratory findings (hypoalbuminemia, hyperbilirubinemia, and/or prolonged prothrombin time), and imaging findings on abdominal ultrasonography, computed tomography, and/or magnetic resonance imaging, with liver biopsy considered when available. The severity of cirrhosis was assessed using the Child-Pugh classification.
Thrombocytopenia was defined as a platelet count <150,000/mm³ and classified as mild (>75,000/mm³), moderate (50,000-75,000/mm³), or severe (<50,000/mm³). Anaemia was defined as haemoglobin <13.5 g/dL in men and <11.5 g/dL in women, and leukopenia as a white blood cell count <4,000/mm³.
Patients were randomly assigned in a 1:1 allocation ratio to the rifaximin group (n=100), which received rifaximin 550 mg orally twice daily for 4 weeks, or the placebo group (n=100). At baseline, all patients underwent clinical evaluation, complete blood count, liver and kidney function tests, and abdominal ultrasonography. A follow-up complete blood count was performed after 4 weeks. Patients were followed weekly in the outpatient hepatology clinic to assess treatment compliance, adverse effects, and cirrhosis-related complications
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 18-75 years with HCV-related liver cirrhosis with SVR and thrombocytopenia.
- •The diagnosis of liver cirrhosis was based on a combination of clinical findings (e.g., splenomegaly, ascites, and/or oesophageal varices), laboratory investigations, and imaging studies, including abdominal ultrasonography, computed tomography, or magnetic resonance imaging. Histological confirmation by liver biopsy was available in selected cases.
排除标准
- •1) Evidence of bacterial infections in the body by:-
- •Clinical history
- •Physical examination
- •Laboratory investigations:
- •WBCs (total and differential count)
- •Urine analysis.
- •Chest X-ray.
- •Ascitic fluid analysis (WBCs & culture and sensitivity) 2) History of variceal bleeding within the 2 weeks preceding this study. 3) Treatment with an antibiotic (including rifaximin) or agents which could have modified the inflammatory process or cytokines (pentoxifylline, steroidal or non-steroidal anti-inflammatory or immunosuppressive drugs) during the last 8 weeks before inclusion.
- •4) Evidence of neoplasia, including hepatocellular carcinoma (HCC). 5) History of red cell or plasma transfusion in the month prior to inclusion in this study.
- •6) History of significant cardiac, pulmonary, renal, or metabolic comorbidities.
- •7) overt hepatic encephalopathy. 8) Active alcohol consumption within the preceding six months. 9) Rifaximin hypersensitivity, 10) Active viral hepatitis requiring direct-acting antiviral therapy 11) Pregnancy or breastfeeding and HIV infection.
研究组 & 干预措施
Rifaximin Placebo
Participants received a placebo twice daily for 4 weeks.
干预措施: Rifaximin Placebo (Other)
Rifaximin
Participants received rifaximin 550 mg orally twice daily for 4 weeks.
干预措施: Rifaximin (drug) (Drug)
结局指标
主要结局
Impact of Rifaximin treatment for four weeks on platelet count
时间窗: Four weeks of treatment
Change in platelet count from baseline to 4 weeks in the rifaximin and placebo groups.
次要结局
- Impact of rifaximin treatment for 4 weeks on haemoglobin level(Four weeks of treatment)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](4 weeks)
- Impact of Rifaximin treatment for four weeks on white blood cell count(Four weeks of treatment)
- Treatment Adherence Rate(Four weeks)
研究者
Eman Mahmoud Fares
Lecturer of Endemic Medicine
Fayoum University Hospital