To Study the Efficacy and Safety of Renessans in Chronic HCV Patients

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MTI Medical Private Limited, Pakistan
• Treatments: Cadexomer iodine; Interferon alpha-2; Interferon-alpha; Interferons; Iodine; Ribavirin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.