An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues

Efficacy and Safety of Peginterferon Alfa-2a (40 KD) in Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment With Nucleoside (Nucleotide) Analogues - an Observational Study in Real-life Clinical Practice

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01794234

Enrollment

Registered

2013-02-18

Start date

2012-08-31

Completion date

2013-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Brief summary

This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>/= 18 years of age * Positive HBsAg for more than 6 months before assignment to treatment with Pegasys * Detectable HBV DNA (as measured by PCR) * HBeAg positive and negative patients * Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard * Elevated serum alanine aminotransferase (ALT) * Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation

Exclusion criteria

* Contraindications to treatment with Pegasys according to the Summary of Product Characteristics * Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver * Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment * Planned other than Pegasys antiviral treatment during Pegasys therapy * Chronic liver disease other than chronic hepatitis B * Pregnant or breast-feeding women * Inadequate hematologic function * Autoimmunology disorders * Co-infection with chronic hepatitis C or HIV

Design outcomes

Primary

Measure	Time frame
Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)	approximately 2.5 years

Secondary

Measure	Time frame
HBs levels in correlation with treatment outcome	approximately 2.5 years
For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)	approximately 2.5 years
For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization	approximately 2.5 years
Safety: Incidence of adverse events	approximately 2.5 years

Countries

Poland

Outcome results