An Open Labelled, Active Controlled, Three Arm, Parallel- Group Study of the Safety and Efficacy of Renessans Administered Alone and in Combination With Standard Interferon Therapy in Patients Chronic HCV Hepatitis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Efficacy of Renessans based triple therapy versus dual therapy
研究概览
简要总结
Chronic HCV infection is one of the common causes of the chronic liver disease. Approximately 6-10% of the general public is expected to be suffering from this infection. In case that these patients are not treated at an appropriate time, these patients develop the sequelae of the chronic liver disease e.g. cirrhosis of liver, Ascites, and Hepatocellular carinoma. Interferon alpha 2 a or alpha 2b injections and Ribavirin combination is the treatment of choice for people suffering from Chronic HCV infection and this combination need to be administered for 6-12 months. Interferons are biological agents and are to be administered parenterally. Interferons are expensive and are associated with number of minor and major adverse effects. Ribavirin is also associated with significant adverse effects. These compounds cannot be considered as one of the ideal forms of the treatment.
In the past, quite a few natural products have been tested to assess their hepatoprotective activity and possibly anti viral activity as well. These include Vitamin C (Ascorbic acid), Vitamin E, Zinc, Silymarin, Red beet roots, crushed licorice and etc. etc.
Rationale Iodine , Potassium iodide and Ascorbic acid are natural products used in the management of Thyroiditis and chronic cutaneous fungal infections. This combination of iodine compounds along with ascorbic acid is being used for the management of chronic hepatitis B & C in the central Asian states e.g. Kazakhstan etc.
The investigators have conducted a feasibility study in which oral Iodine Compound {RENESSANS} was given to patients suffering HCV related Chronic Active Hepatitis and anti-viral activity and safety has been analyzed. In this study, RENESSANS containing regimen has been well tolerated by all the patients and has shown some antiviral activity.
In this study the investigators will assess whether the administration of RENESSANS {oral } improves the antiviral activity in patients receiving standard interferon therapy.
详细描述
- Primary
The primary objective of this study is to assess the efficacy of combination therapy comprising of RENESSANS, INTERFERONS and RIBAVIRIN in the management of treatment naïve HCV related Chronic Active Hepatitis patients. 2. Secondary
The secondary objectives of this study are:
- Determine the biochemical or virological improvement in patients suffering from HCV related Chronic Active Hepatitis.
- Determine the safety and tolerability of Renessans {oral} when administered as a part of antiviral activity outlined in this protocol.
- ENDPOINTS
The primary endpoint will be the number of subjects achieving
- Virological response as evident by Rapid Viral Response(RVR), Early Viral Response(EVR) and Sustained Viral Response(SVR).
- Biochemical response as evident by normalization of ALT.
The secondary endpoint will be
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Following groups of the people will be enrolled for the study.
- •Patients suffering from chronic HCV infection as evident with a positive serology for Anti HCV antibody and raised ALT.
- •Both males and females
- •Age group: 18 - 55 years
- •Informed consent
排除标准
- •Following groups of people will be excluded from the study
- •Pregnant females
- •Body mass index more than 25
- •Uncontrolled Diabetes Mellitus, Hypertension, Ischemic heart disease, Renal failure, Respiratory failure, Chronic infections, gall stone disease or renal stone disease.
- •Patients known to have hypersensitivity to Iodine compounds in the past.
- •Psychiatric disorders except mild anxiety disorders.
- •Patients suffering from auto immune diseases e.g. Rheumatoid Arthritis, SLE, or thyroid diseases.
- •Patients suffering from concomitant HBV infection, HIV infection or any other chronic liver disease.
- •Bilirubin more than 2mg/dl, Albumin less than 3.0 gms/dl, INR more than 1.5, Hb. less than 10 gms /dl, absolute neutrophil count less than 1500/cmm and platelet count less than 100,000/cmm
- •Serum sodium less than 130mmol/l.
- •Patients who have received the interferon treatment in the past.
研究组 & 干预措施
Group II a
TRIPPLE THERAPY
干预措施: RENESSANS , INTERFERON ALPHA 2b, Ribavirin (Biological)
Group II b
DUAL THERAPY
干预措施: Interferon Alfa-2b AND RIBAVIRIN (Drug)
Group I
ORAL RENESSANS
干预措施: RENESSANS (Biological)
结局指标
主要结局
Efficacy of Renessans based triple therapy versus dual therapy
时间窗: 03 years
Efficacy will be assessed by biochemical and virological response. Biochemical response will be assessed in the form of mean decline in ALT from baseline at 3 month and end of treatment. Virological response will be assessed in the form of response guided therapy i-e RVR \[negative RNA at week 4\],EVR \[negative RNA at 12 weeks\],ETR \[negative RNA at end of treatment\] and SVR\[negative PCR after 6 month of completion of therapy\].
次要结局
- Assess the safety and tolerability of Renessans in patients with chronic HCV patients(3.5 years)