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

This study is currently recruiting participants.
Verified November 2012 by Fundacion IMIM
Sponsor:
Information provided by (Responsible Party):
Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT01033045
First received: December 15, 2009
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition
Hepatitis C

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundacion IMIM:

Primary Outcome Measures:
  • Describe the management of patients with chronic hepatitis C and previous treatment failure [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2196
Study Start Date: September 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients of both sexes older than 18 years old with hepatitis C who had previously failed to the standard therapy.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033045

Contacts
Contact: Ricard Solà Lamoglia, Dr. 932483218 35783m@imas.imim.es
Contact: Carola Llonch +034 93 316 1678 ext 1758 cllonch@imim.es

  Show 111 Study Locations
Sponsors and Collaborators
Fundacion IMIM
Investigators
Principal Investigator: Ricard Solà Lamoglia, Dr. Hospital del Mar, Barcelona
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
  More Information

No publications provided

Responsible Party: Fundacion IMIM
ClinicalTrials.gov Identifier: NCT01033045     History of Changes
Other Study ID Numbers: AGORA
Study First Received: December 15, 2009
Last Updated: November 13, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacion IMIM:
Hepatitis C
Viral
Non-A
Non-B
Parenterally-Transmitted

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013