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

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01794234
• Other study ID #: ML28346
• Status: Terminated
• Phase: N/A
• First received: February 15, 2013
• Last updated: November 1, 2016
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	HBs levels in correlation with treatment outcome		approximately 2.5 years	No
Secondary	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	No
Secondary	For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization		approximately 2.5 years	No
Secondary	Safety: Incidence of adverse events		approximately 2.5 years	No