Hepatitis C
Conditions
Keywords
Hepatitis C, Viral, Non-A, Non-B, Parenterally-Transmitted
Brief summary
The purpose of this study is to describe the management of patients with chronic hepatitis C and previous treatment failure.
Interventions
None listed
Sponsors
Fundacion IMIM
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes older than 18 years old. * Patients with hepatitis C who had previously failed to the standard therapy. * Patients who have given written informed consent to participate in the study.
Exclusion criteria
* Patients with clinical and/or social conditions that might interfere with the development of the study (terminal diseases, cognitive detriment, severe psychiatric disease which prevent from obtaining the information required, prolonged absences during the study). * Patients who are participating in other research trials or under treatment with any agent contraindicated according to the summary of product characteristics or other circumstance which requires a patient management different from the investigator's regular clinical practice.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Describe the management of patients with chronic hepatitis C and previous treatment failure | 6 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes. | 6 years | — |
| To evaluate the implementation of current recommendations based on the cause of the previous therapeutic failure, in patients with chronic hepatitis C in whom a new course of the antiviral treatment is decided to be administered. | 6 years | — |
| To know the causes of the dose modifications and withdrawal of treatment during the follow-up period in patients who start re-treatment. | 6 years | — |
| To know the frequency of the causes for not responding to the previous treatment: lack of adherence to treatment, incomplete dose of antiviral treatment, insufficient treatment duration or treatment resistance. | 6 years | — |
| To determine the presence of the polymorphism rs12979860 in the gene IL 28B located on chromosome 19. | 6 | The rs12979860 polymorphism in the gene IL 28B that is located on chromosome 19 showed to be strongly associated with the development of sustained viral response (SVR) in patients with chronic hepatitis C treated with PEG-IFN-α/RBV. Patients with this polymorphism clear the virus more easily. |
| Compare the management of patients with chronic hepatitis C prior treatment failure before and after the appearance of new treatments. | 3 | — |
| To know the percentage of patients that achieve sustained viral response when implementing the recommendations based on the cause of the previous therapeutic failure. | 6 years | — |
Countries
Spain
Outcome results
None listed