Health Condition 1: B191- Unspecified viral hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Age above 18 years -ECOG- performance status of 0 or 1 -Chronic HBV infection with HBV DNA levels more than equal to 2000 IU per mL and normal ALT alanine amino transferase These patients are not routinely treated with antivirals due to limited activity. ALT is traditionally considered to be marker of hepatocellular injury. Various studies using interferon, peg interferon, Lamivudine, Adefovir have shown the importance of elevated ALT levels in predicting the response rate to therapy -Chronic HCV infection with detectable HCV RNA levels and Genotype 2 or -who are eligible for antiviral treatment as per standard guidelines -No active malignancy at least 1 year of DFS following successful anticancer Rx -Adequate hepatic, renal, and hematologic function at baseline -Patients who have given written informed consent
Exclusion criteria
Exclusion criteria: -Age more 60 years -Any other Genotype of HCV -Acute Hepatitis -Cirrhosis -Decompensated chronic liver disease -Concurrent chemotherapy -Current or previous antiviral treatment for HBV or HCV -Coexistent dual infection- i.e. HBV with HCV -Coexistent HIV infection -Uncontrolled medical comorbidities like hypertensive, diabetes mellitus -Patients taking alternative/ complementary treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate change in the viral load after oral administration of R-Cu in a four times daily dosing for 4 weeksTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of R-Cu in patients with chronic hepatitis B and CTimepoint: 2 years | — |
Countries
India
Contacts
Tata Memorial Hospital