A Pilot Study to Assess the Efficacy and Safety of Folic Acid and/or Vitamin B Complex on Hepatitis C Infected Patients Treated With Pegylated Interferon and Ribavirin.
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Effect of folic acid and/or Vitamin B complex to prevent adverse effect of pegylated interferon and ribavirin
研究概览
简要总结
Since success of the combination therapy with PEG-IFN and RBV is contingent on maintaining adequate doses of both drugs throughout the treatment period, the emergence of hematological side effects is expected and requires intervention. The hematological adverse effects lead to a trade-off between continuing the treatment with optimal dosage, to clear the virus, exacerbating thereby the side effects versus decreasing dosage to relieve severe anemia, reducing thereby the chances of achieving sustained virological response (SVR). Therefore, we aimed at giving Folic acid® and Neurobion® to HCV-infected patients during treatment with different types of PEG-IFN plus ribavirin in an attempt to evaluate its efficacy and safety as a prophylactic treatment to prevent hematological adverse effects. Preventing adverse effects without interfering with the therapeutic efficacy of different types of PEG-IFN plus ribavirin in HCV patients will lead to better health outcomes and improvement in their quality of life (HRQOL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C patients of both sexes were eligible for inclusion if they were HCV RNA positive, naive to PEG-INF and RBV, and had abnormal serum alanine transaminase levels on two occasions during the preceding six months.
排除标准
- •Patients with significant hematological abnormalities at baseline, such as neutropenia (ANC <1200 x 103 cells/µL), thrombocytopenia (<70 x 103 cells/ µL), and anemia (<10.5 g/dL), were excluded. Patients were also excluded from study participation if they had serum creatinine ≥1.70 mg/dL (150 µmol), hepatitis B surface antigen positivity, decompensated cirrhosis, or other forms of liver disease not attributable to HCV. Patients with severe depression or psychosis, uncontrolled seizures, poorly controlled cardiovascular disease, diabetes mellitus, or autoimmune disorders were also ineligible. Women were ineligible for study participation if they were pregnant or unwilling to use at least 2 forms of effective contraception during the entire study period.
研究组 & 干预措施
Group D
Patients will receive matching placebo capsule to take during hepatitis C treatment
干预措施: placebo (Drug)
Group A
one capsule of 5 mg of Folic acid twice daily and a tablet of Neurobion three times per day during hepatitis C treatment
干预措施: Folic acid (Dietary Supplement)
Group A
one capsule of 5 mg of Folic acid twice daily and a tablet of Neurobion three times per day during hepatitis C treatment
干预措施: Neurobion (Drug)
Group B
Patients will receive one capsule of 5 mg of Folic acid twice daily during hepatitis C treatment
干预措施: Folic acid (Dietary Supplement)
Group C
Patients will receive a tablet of Neurobion three times per day during hepatitis C treatment
干预措施: Neurobion (Drug)
结局指标
主要结局
Effect of folic acid and/or Vitamin B complex to prevent adverse effect of pegylated interferon and ribavirin
时间窗: 1 YEAR
Maintain absolute neutrophil count (ANC) levels \>750 cells/mm3, hemoglobin levels \>10.5 g/dL to prevent adjustment to the PEG-INF dose or its temporary suspension. Moreover, to maintain a sustained platelet level above 45,000 platelet/mm3. During therapy thrombocytopenia was assessed at levels of 50,000 and 25,000/µl, since these levels are the usual thresholds for dose reductions or discontinuation of peginterferon alfa/ribavirin therapy.
次要结局
- Effect of folic acid and/or Vitamin B complex on the efficacy of pegylated interferon and ribavirin.(1 year and 6 month after end of treatment)
研究者
Nermeen Nabil Ashoush
Lecturer Assistant in Clinical Pharmacy Department
British University In Egypt