pre-cirrhotic chronic hepatitis B virus (HBV) infection
Conditions
Interventions
Trade Name: Peginterferon alfa 2a
Product Name: Peg interferon alfa-2a
Product Code: RO 25-8310
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Epivir-HBV (lamiudine)
Z
Sponsors
Southampton University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this study, patients must have the following documented: 1. Age > 18 years 2. Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA (patients must have >100,000 iu/ml (>500,000 copies/ml) as measured by PCR) 3. Elevated serum ALT > 1.1 x ULN but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Histological or clinical evidence of established cirrhosis · HIV co-infection (written consent will be taken for the HIV testing and counselling offered) · HCV or HDV co-infection · Renal impairment: serum creatinine >1.5 ULN · Neurological/psychiatric disorder · Severe cardiac or pulmonary disease · History or other evidence of severe retinopathy · Severe seizure disorder or current anti-convulsant use · Active or suspected cancer or a history of malignancy where the risk of recurrence is greater than 20% within 2 years. · Any other significant systemic disease, including thyroid disease · Unable to conform to study protocol due to alcohol use in excess of 20gms/day or drug abuse · Alcohol abuse [alcohol in excess of safe limits of 28 units/ week for men and 21 units/week for women] and/or intravenous drug abuse within 1 year of entry · A medical condition associated with chronic liver disease other than viral hepatitis · Neutrophil count 2 x ULN · Anti-viral treatment with interferon alpha or nucleoside analogue within 18 months · Previous treatment with Lamivudine for > 12 months · Evidence of emergence of Lamivudine resistant HBV · Any research study within previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To gain an understanding of the cellular immune responses to HBV associated with standard Pegasys monotherapy versus Lamivudine priming of Pegasys [in two regimens] in HBeAg positive patients. ;Secondary Objective: To evaluate the relationship between early immunological and virological parameters with outcome of standard Pegasys monotherapy versus Lamivudine priming of Pegasys [in two regimens] in HBeAg positive chronic hepatitis B.;Primary end point(s): · Serious or life-threatening adverse event · Subject is found to be in violation of the protocol exclusion criteria · Failure to comply with the dosing, evaluations or other requirements of the study · Request of the subject (subjects have the right to discontinue treatment at any time for any reason) · Subject becomes pregnant · The investigator feels that discontinuation is in the best interest of the subject | — |
Countries
United Kingdom
Outcome results
None listed