An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
Launched by HOFFMANN-LA ROCHE · Feb 15, 2013
Trial Information
Current as of May 30, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Krakow, , Poland
Debica, , Poland
Gdansk, , Poland
Wroclaw, , Poland
Bytom, , Poland
Myslowice, , Poland
Lancut, , Poland
Raciborz, , Poland
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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