An Observational/Non-interventional, Study of NS3/4a Protease and NS5A Protein of Hepatitis C Virus in Brazilian Participants With Chronic HCV Infection
Launched by JANSSEN-CILAG LTD. · Nov 3, 2015
Trial Information
Current as of April 30, 2025
Completed
Keywords
ClinConnect Summary
This is a multicenter, observational/non-interventional, cross-sectional study to describe the genetic diversity of and to identify the natural polymorphisms in HCV NS3/4a protease and NS5A protein of hepatitis C virus in Brazilian participants with chronic HCV infection. Brazilian participants with Genotype 1 HCV infection treatment naive participants or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial and will constitute the trial population.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants mono infected with chronic Hepatitis C infection (genotype 1), including naive patients or previously failed to double therapy (Peg-interferon-α and Ribavirin)
- • There is no restriction on fibrosis stage or clinical liver disease
- • There is no restriction for comorbidities
- • Male or female participants with age \>=18 years
- Exclusion Criteria:
- • Participants failed to triple therapy using protease inhibitors
- • Participants with co-infections (i.e. Human immunodeficiency virus, Hepatitis B virus)
- • Participants that are not agree to sign the written informed consent
- • Participants is taking part in an interventional clinical trial with an investigational agent (i.e. non-commercialized agent) or in an interventional clinical trial sponsored by Johnson \& Johnson
About Janssen Cilag Ltd.
Janssen-Cilag Ltd. is a global pharmaceutical company dedicated to addressing the unmet medical needs of patients through innovative research and development. As a subsidiary of Johnson & Johnson, it specializes in the discovery, development, and commercialization of advanced therapies across various therapeutic areas, including immunology, oncology, neuroscience, and infectious diseases. Committed to improving patient outcomes, Janssen-Cilag Ltd. engages in robust clinical trials and collaborations with healthcare professionals, ensuring that cutting-edge treatments are accessible and effective. With a strong focus on science and a patient-centered approach, the company strives to enhance the quality of life for individuals worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sao Paulo, , Brazil
Porto Alegre, , Brazil
Salvador, , Brazil
Goiânia, , Brazil
Belém, , Brazil
Porto Velho, , Brazil
Patients applied
Trial Officials
Janssen-Cilag Ltd. Clinical Trial
Study Director
Janssen-Cilag Ltd.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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