An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure
Launched by HOFFMANN-LA ROCHE · Feb 22, 2013
Trial Information
Current as of August 11, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult participants, \>/= 18 years of age
- • Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin
- • No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label
- * Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:
- • Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA)
- • Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment
- • No co-infection with hepatitis B or human immunodeficiency virus (HIV)
- Exclusion Criteria:
- • History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
- • History of neurological disease
- • History of severe psychiatric disease
- • Decompensated diabetes
- • History of immunologically mediated disease
- • History of severe cardiac disease
- • History or evidence of severe chronic pulmonary disease
- • Inadequate hematologic function
- • Pregnant or breastfeeding women
- • Male partners of pregnant women
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
Brasov, , Romania
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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