Patients with chronic hepatitis B, HBeAg-negative, on treatment with nucleos(t)ide analogues. MedDRA version: 9.1 Level: HLGT Classification code 10019654 Term: Hepatic and hepatobiliary disorders
Conditions
Interventions
Trade Name: PEGASYS
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Peginterferon alfa-2a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration num
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Chronic hepatitis B anti-HBe positive or Cirrhosis Child-Pugh A5 without portal hypertension signs on analogue treatment 2. Age 18-65 years 3. HBV DNA > 60 IU/mL to 2,000 IU/mL (HBV DNA > 300 cp/mL to 10,000 cp/mL) at least six months of therapy OR HBV-DNA increase ³ 1log10 but =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. ALT > 10 ULN 2. Presence of cirrhosis with a Child-Pugh score > 5, esophageal varices ≥ F2, history or evidence of ascites or bleeding 3. A positive result in HBeAg, HCV, anti-HDV or HIV tests 4. History or evidence of other causes of liver disease associated to HBV (haemochromatosis, alcoholic hepatitis, etc) 5. Autoimmune diseases; 6. A neutrophil count 1.5 the ULN 9. Significant renal disease 10. AFP >100 ng/mL; patients with AFP values >20 but 30 g/dL for men or 20 g/dL for women 14. Drug abuse 15. History of seizures or use of anti-epileptic drugs 16. Heart disease (NYHA 3 or 4) or other significant heart abnormality 17. Organ transplant recipients 18. Uncontrolled thyroid dysfunction 19. Retinal diseases 20. If female of child-bearing potential, a positive urine pregnancy test 21. Lactating women 22. Participation in an investigational drug study within three months prior to screening 23. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study 24. Any confirmed significant allergic reactions against any drug, or multiple allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To assess the efficacy of Peginterferon alfa-2a for 48 weeks used in monotherapy after 4 weeks of combination with nucleos(t)ide in patients with chronic hepatitis B, HBeAg-negative who present residual viremia or virological rebound during nucleos(t)ide analogues treatment.;Secondary Objective: Secondary: To assess the safety of Peginterferon alfa-2a for 48 weeks used in monotherapy after 4 weeks of combination with nucleos(t)ide in patients with chronic hepatitis B, HBeAg-negative who present residual viremia or virological rebound during nucleos(t)ide analogues treatment.;Primary end point(s): Primary Endpoint: The reduction of HBV-DNA levels to below 2,000 IU/mL (10,000 cp/mL) after 24 weeks of untreated follow-up period. | — |
Countries
Italy
Outcome results
None listed