Patients with chronic HBeAg-negative hepatitis B with a stable oral antiviral treatment (not containing telbivudine) and a fully suppressed viral load for at least 12 months (below limit of detection in conventional HBV-PCR assays, i.e. <116 IU / ml). MedDRA version: 20.0 Level: LLT Classification code 10019738 Term: Hepatitis B positive System Organ Class: 100000109834
Conditions
Interventions
Trade Name: Pegasys® 135/180 Mikrogramm
Product Name: Pegasys® 135/180 Mikrogramm
Product Code: L03A B11
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: PEGINTER
Sponsors
University Medical Center of the Johannes Gutenberg University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Chronic hepatitis B, HBe antigen negative • Treatment with a stable oral antiviral treatment (not containing telbivudine) and a fully suppressed viral load for at least 12 months (below limit of detection in conventional HBV-PCR assays, i.e. =65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: • HBe antigen positive Hepatitis B • Co-infection with HCV, HDV or HIV – as based on positive serology or PCR • Ongoing antiviral treatment with Telbivudine • Contraindications against treatment with pegylated interferon, e.g. severe depression, epilepsy, autoimmune diseases, pregnancy, leukocytopenia or thrombocytopenia at screening, etc. • Preexisting polyneuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to investigate whether the add-on of pegylated interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the percentage of patients who have significant decrease (=1log10) of HBs-antigen after 48 weeks.;Secondary Objective: • To evaluate safety and tolerability of pegylated interferon alfa-2a when combined with tenofovir, entecavir, lamivudine, adefovir, or a combination of those: - Adverse events - Vital signs, physical examination - Laboratory test abnormalities - Laboratory test value changes over time •To identify biological variables predicting HBs antigen decrease: - viral genotype - kinetic of HBs antigen level • To determine the effect of pegylated interferon on frequency and functional properties of HBV-specific cytotoxic and regulatory T-cells in responder and nonresponder patients ;Primary end point(s): The primary endpoint is the objective response after 48 weeks of therapy. The response is defined as a confirmed reduction of =1log10 in HBs antigen compared to baseline.;Timepoint(s) of evaluation of this end point: After 48 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Decline of quantitative HBs antigen at week 12 and 24 2. Rate of patients with at least 10% HBs antigen loss at week 24 compared to baseline 3.HBsAg seroconversion defined as percentage of subjects who become HBsAg negative and anti-HBs positive during the observation period 4.Safety and tolerability of pegylated interferon alfa-2a when added to a continuing treatment with tenofovir, entecavir, lamivudine, adefovir, or a combination of those: Analysis of adverse events and laboratory data. ;Timepoint(s) of evaluation of this end point: add 1. at week 12 and 24 add 2. at week 24 add 3. at week 1 - 72 add 4. at week 1 - 72 | — |
Countries
Germany
Contacts
Public ContactPeter Galle
University Medical Center of the Johannes Gutenberg University Mainz
Outcome results
None listed