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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ricard Sola, Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT01033045
First received: December 15, 2009
Last updated: February 11, 2016
Last verified: February 2016

December 15, 2009
February 11, 2016
September 2009
July 2013   (final data collection date for primary outcome measure)
Describe the management of patients with chronic hepatitis C and previous treatment failure [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Describe the management of patients with chronic hepatitis C and previous treatment failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01033045 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine the presence of the polymorphism rs12979860 in the gene IL 28B located on chromosome 19. [ Time Frame: 6 ] [ Designated as safety issue: No ]
    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. [ Time Frame: 3 ] [ Designated as safety issue: No ]
  • 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: 3 years ] [ Designated as safety issue: No ]
  • To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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: 3 years ] [ Designated as safety issue: No ]
  • 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: 3 years ] [ Designated as safety issue: No ]
  • 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: 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients of both sexes older than 18 years old with hepatitis C who had previously failed to the standard therapy.
Hepatitis C
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2178
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01033045
AGORA
Yes
Not Provided
Not Provided
Ricard Sola, Fundacion IMIM
Fundacion IMIM
Not Provided
Principal Investigator: Ricard Solà Lamoglia, Dr. Hospital del Mar
Principal Investigator: Ramón Planas Vila, Dr. Hospital Germans Tries i Pujol, Barcelona
Principal Investigator: Javier García-Samaniego, Dr. Hospital Carlos III, Madrid
Principal Investigator: Moisés Diago, Dr. Hospital General de Valencia
Principal Investigator: Manuel Romero, Dr. Hospital de Valme, Sevilla
Principal Investigator: José Luís Calleja, Dr Hospital Puerta del Hierro, Madrid
Fundacion IMIM
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP