Clinical trial NCT01794234: An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-02-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B initiated on therapy with Pegasys

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)
timeFrame: approximately 2.5 years
Secondary outcomes:
measure: HBs levels in correlation with treatment outcome
timeFrame: approximately 2.5 years
measure: 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)
timeFrame: approximately 2.5 years
measure: For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization
timeFrame: approximately 2.5 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 2.5 years
Other outcomes:
Locations:
city: Bytom
country: Poland
city: Debica
country: Poland
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lancut
country: Poland
city: Myslowice
country: Poland
city: Raciborz
country: Poland
city: Wroclaw
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: