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Completed

NCT Number: NCT01033045

Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure

The purpose of this study is to describe the management of patients with chronic hepatitis C and previous treatment failure.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

H. de Antequera, Antequera, Andalusia, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Describe the management of patients with chronic hepatitis C and previous treatment failure

    Time frame: 6 years

Secondary outcomes

  1. 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.

    Time frame: 6 years

  2. To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes.

    Time frame: 6 years

  3. 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.

    Time frame: 6 years

  4. To know the causes of the dose modifications and withdrawal of treatment during the follow-up period in patients who start re-treatment.

    Time frame: 6 years

  5. To know the percentage of patients that achieve sustained viral response when implementing the recommendations based on the cause of the previous therapeutic failure.

    Time frame: 6 years

  6. To determine the presence of the polymorphism rs12979860 in the gene IL 28B located on chromosome 19.

    Time frame: 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.

  7. Compare the management of patients with chronic hepatitis C prior treatment failure before and after the appearance of new treatments.

    Time frame: 3

Sponsors and collaborators

Lead sponsor

Fundacion IMIM

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 16, 2009
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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