To Study the Efficacy and Safety of Renessans in Chronic HCV Patients
To Study the Efficacy and Safety of Renessans in Chronic HCV Patients
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.
1. 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:

 1. Determine the biochemical or virological improvement in patients suffering from HCV
 related Chronic Active Hepatitis.

 2. Determine the safety and tolerability of Renessans {oral} when administered as a
 part of antiviral activity outlined in this protocol.

 3. ENDPOINTS

 The primary endpoint will be the number of subjects achieving

 1. Virological response as evident by Rapid Viral Response(RVR), Early Viral
 Response(EVR) and Sustained Viral Response(SVR).

 2. Biochemical response as evident by normalization of ALT.

 The secondary endpoint will be

 a. Assessment of the safety and tolerability of RENESSANS through: routine physical
 examination, routine clinical laboratory tests, clinical monitoring and adverse events
 reporting.

 4. INVESTIGATIONAL PLAN

 Study Design.

 This is an open labeled, active controlled, three arm, parallel-group study of the
 safety and efficacy of the oral formulation of natural iodine compound (Renessans)
 administered alone and in combination with standard interferon therapy in patient
 suffering from chronic HCV hepatitis.

 The enrolled patients will be tested for following base line laboratory tests

 VISIT 1:

 CBC including platelet count and ESR Liver function tests including albumin and total
 proteins. Creatinine Serum electrolytes Thyroid Function tests HBsAg, HIV antibody
 Urinalysis ANA, RA factor and serum ferritin levels USG of abdomen HCV RNA (PCR by
 amplicor, roche) qualitative analysis, if positive then quantitative analysis (Real
 time) and genotype as well.

 Pregnancy test in case of females Informed consent shall be obtained and each individual
 patient's treatment risk shall be covered under a certified health insurance plan.

 Renessans will be administered in eligible patients as follows:

 Study Arm Dosing Schema Group I ORAL RENESSANS 5gm. Thrice Daily{active iodine 300mg}
 for 6months Group II a ORAL RENESSANS 5gm. Twice Daily +INTERFERON ALPHA 2b 3 Million
 Units s/c +RIBAVIRIN 15mg/kg Group II b INTERFERON ALPHA 2b 3 Million Units s/c
 +RIBAVIRIN 15mg/kg Blood samples shall be collected and stored for post - hoc analysis
 of HCV RNA at day 1, 7 and 15(visit 2,3 & 4).

 Patients will be reviewed for the hepatoprotection, anti viral activity and any adverse
 event every four weeks with following clinical and lab work.

 VISIT 5 Detailed history and physical examination Following lab. Investigations at week
 4. CBC including platelet count and ESR Liver function tests including albumin and total
 proteins. Creatinine Serum electrolytes Thyroid Function tests Ferritin HCV RNA (PCR)
 quantitative analysis VISIT 6 Detailed history and physical examination Following lab.
 Investigations at week 8. CBC including platelet count and ESR Liver function tests
 including albumin and total proteins. Creatinine Serum electrolytes

 VISIT 7 Detailed history and physical examination Following lab. Investigations at week
 12. CBC including platelet count and ESR Liver function tests including albumin and
 total proteins. Creatinine Serum electrolytes Thyroid Function tests Ferritin HCV RNA
 (PCR) quantitative analysis

 VISIT 8 Detailed history and physical examination Following lab. Investigations at week
 16. CBC including platelet count and ESR Liver function tests including albumin and
 total proteins. Creatinine Serum electrolytes VISIT 9 Detailed history and physical
 examination Following lab. Investigations at week 20. CBC including platelet count and
 ESR Liver function tests including albumin and total proteins. Creatinine Serum
 electrolytes VISIT 10 Detailed history and physical examination Following lab.
 Investigations at week 24. CBC including platelet count and ESR Liver function tests
 including albumin and total proteins. Creatinine Serum electrolytes VISIT 11 Detailed
 history and physical examination Following lab. Investigations at week 28. CBC including
 platelet count and ESR Liver function tests including albumin and total proteins.
 Creatinine Serum electrolytes VISIT 12 Detailed history and physical examination
 Following lab. Investigations at week 32. CBC including platelet count and ESR Liver
 function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT
 13 Detailed history and physical examination Following lab. Investigations at week 36.
 CBC including platelet count and ESR Liver function tests including albumin and total
 proteins. Creatinine Serum electrolytes VISIT 14 Detailed history and physical
 examination Following lab. Investigations at week 40. CBC including platelet count and
 ESR Liver function tests including albumin and total proteins. Creatinine Serum
 electrolytes VISIT 15 Detailed history and physical examination Following lab.
 Investigations at week 44. CBC including platelet count and ESR Liver function tests
 including albumin and total proteins. Creatinine Serum electrolytes VISIT 16 Detailed
 history and physical examination Following lab. Investigations at week 48. CBC including
 platelet count and ESR Liver function tests including albumin and total proteins.
 Creatinine Serum electrolytes VISIT 15 Detailed history and physical examination
 Following lab. Investigations at week 52. CBC including platelet count and ESR Liver
 function tests including albumin and total proteins. Creatinine Serum electrolytes VISIT
 15 Detailed history and physical examination Following lab. Investigations at week 60.
 CBC including platelet count and ESR Liver function tests including albumin and total
 proteins. Creatinine Serum electrolytes

 VISIT 16 Detailed history and physical examination Following lab. Investigations at week
 72. CBC including platelet count and ESR Liver function tests including albumin and
 total proteins. Creatinine Serum electrolytes Thyroid Function tests Ferritin HCV RNA
 (PCR) quantitative analysis
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.