CClinicalTrials.gg
CompletedNCT01033045Updated Feb 12, 2016

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

An observational study in Hepatitis C, sponsored by Fundacion IMIM. Completed at 104 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-12.

Sponsored by Fundacion IMIM · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
2,178
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hepatitis C

Keywords

  • Hepatitis C
  • Viral
  • Non-A
  • Non-B
  • Parenterally-Transmitted
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 2,178 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Fundacion IMIM is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Time perspective
Prospective
Enrollment
2,178 participants (actual)
06

What researchers measure

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.

    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.

    Time frame: 6

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

    Time frame: 3

07

Study locations

104 sites
  • H. de Antequera
    Antequera, Andalucía, Spain
  • H. Puerta de Mar
    Cádiz, Andalucía, Spain
  • H. Puerto Real
    Cádiz, Andalucía, Spain
  • H. Vírgen de las Nieves
    Granada, Andalucía, Spain
  • H. Infanta Elena
    Huelva, Andalucía, Spain
  • H. de Jaen
    Jaen, Andalucía, Spain
  • H. de Jerez
    Jerez de la Frontera, Andalucía, Spain
  • H. Carlos Haya
    Málaga, Andalucía, Spain
  • H. Vírgen de la Victoria
    Málaga, Andalucía, Spain
  • H. de Valme
    Sevilla, Andalucía, Spain
  • H. San Jorge
    Huesca, Aragón, Spain
  • H. Clínico de Zaragoza
    Zaragoza, Aragón, Spain
  • H. Miquel Servet
    Zaragoza, Aragón, Spain
  • H. Central de Astúrias
    Oviedo, Astúrias, Spain
  • H. Carlos III
    Madrid, C de Madrid, Spain
  • H. de Henares
    Alcalá de Henares, C. de Madrid, Spain
  • Fundación de Alcorcón
    Alcorcón, C. de Madrid, Spain
  • H. de Getafe
    Getafe, C. de Madrid, Spain
  • H. 12 de Octubre
    Madrid, C. de Madrid, Spain
  • H. Fundación Jiménez Díaz
    Madrid, C. de Madrid, Spain
  • H. la Paz
    Madrid, C. de Madrid, Spain
  • H. la Princesa
    Madrid, C. de Madrid, Spain
  • H. Príncipe de Astúrias
    Madrid, C. de Madrid, Spain
  • H. Severo Ochoa
    Madrid, C. de Madrid, Spain
  • H. de Móstoles
    Móstoles, C. de Madrid, Spain
  • H. Infanta Cristina
    Parla, C. de Madrid, Spain
  • H. Infanta Sofía
    San Sebastian de los Reyes, C. de Madrid, Spain
  • H. de Alcoy
    Alcoy, C. Valenciana, Spain
  • H. General de Alicante
    Alicante, C. Valenciana, Spain
  • H. Marina Baixa
    Alicante, C. Valenciana, Spain
  • H. de Castellón
    Castellón, C. Valenciana, Spain
  • H. de Elche
    Elche, C. Valenciana, Spain
  • H. Vega Baja
    Orihuela, C. Valenciana, Spain
  • H. Clínico de Valencia
    Valencia, C. Valenciana, Spain
  • H. General de Valencia
    Valencia, C. Valenciana, Spain
  • H. de Xàtiva
    Xàtiva, C. Valenciana, Spain
  • H. Insular
    Gran Canaria, Canarias, Spain
  • H. Dr. José Molina Orrosos
    Lanzarote, Canarias, Spain
  • H. Candelaria
    Tenerife, Canarias, Spain
  • H. Dr. Negrín
    Tenerife, Canarias, Spain
  • H. Universitario de Tenerife
    Tenerife, Canarias, Spain
  • H. de Valdecilla
    Santander, Cantabria, Spain
  • H. de Albacete
    Albacete, Castilla la Mancha, Spain
  • H. Ciudad Real
    Ciudad Real, Castilla la Mancha, Spain
  • H. de Cuenca
    Cuenca, Castilla la Mancha, Spain
  • H. de Manzanares
    Manzanares, Castilla la Mancha, Spain
  • H. Alcázar
    Toledo, Castilla la Mancha, Spain
  • H. Vírgen de la Salud
    Toledo, Castilla la Mancha, Spain
  • H, de Tomelloso
    Tomelloso, Castilla la Mancha, Spain
  • H. de Valdepeñas
    Valdepeñas, Castilla la Mancha, Spain
  • H. de León
    León, Castilla y León, Spain
  • H. Comarcal el Bierzo
    Ponferrada, Castilla y León, Spain
  • H. Clínico de Salamanca
    Salamanca, Castilla y León, Spain
  • H. Clinico de Valladolid
    Valladolid, Castilla y León, Spain
  • H. Río Ortega
    Valladolid, Castilla y León, Spain
  • H. Germans Trias Pujol
    Badalona, Cataluña, Spain
  • H. Clínic
    Barcelona, Cataluña, Spain
  • H. Sant Boi
    Barcelona, Cataluña, Spain
  • H. Sant Pau
    Barcelona, Cataluña, Spain
  • Hospital de Bellvitge
    Barcelona, Cataluña, Spain
  • Xarxa Sanitaria i Social de Santa Tecla (Tarragona)
    El Vendrell, Cataluña, Spain
  • H. de Figueres
    Figueres, Cataluña, Spain
  • H. Josep Trueta
    Girona, Cataluña, Spain
  • H. Santa Caterina
    Girona, Cataluña, Spain
  • H. General de Igualada
    Igualada, Cataluña, Spain
  • H. Sant Joan de Déu de Manresa
    Manresa, Cataluña, Spain
  • H. Sant Joan de Déu de Martorell
    Martorell, Cataluña, Spain
  • H. Sant Joan de Reus
    Reus, Cataluña, Spain
  • H. Parc Taulí de Sabadell
    Sabadell, Cataluña, Spain
  • H. Esperit Sant
    Santa Coloma de Gramanet, Cataluña, Spain
  • H. Joan XXIII
    Tarragona, Cataluña, Spain
  • H. Verge de la Cinta de Tortosa
    Tortosa, Cataluña, Spain
  • H. General de Vic
    Vic, Cataluña, Spain
  • H. de Viladecans
    Viladecans, Cataluña, Spain
  • H. Infanta Cristina
    Badajoz, Extremadura, Spain
  • H. de Coria/Plasencia
    Coria, Extremadura, Spain
  • H. San Pedro Alcántara
    Cáceres, Extremadura, Spain
  • H. de Mérida
    Mérida, Extremadura, Spain
  • Complejo Hospitalario Universitario A Coruña
    A Coruña, Galicia, Spain
  • Complexo Hospitalario Universitario A Coruña
    A Coruña, Galicia, Spain
  • H. Arquitecto Marcide
    Ferrol, Galicia, Spain
  • Complexo Hospitalario Ourense
    Ourense, Galicia, Spain
  • Complexo Hospitalario Pontevedra
    Pontevedra, Galicia, Spain
  • Complexo Hospitalario Universitario de Santiago
    Santiago de Compostela, Galicia, Spain
  • Complejo hospitalario Vigo
    Vigo, Galicia, Spain
  • H. Meixoeiro
    Vigo, Galicia, Spain
  • H. Xeral Cíes
    Vigo, Galicia, Spain
  • POVISA
    Vigo, Galicia, Spain
  • H. Son Dureta
    Mallorca, Illes Balears, Spain
  • H. Son Llàtzer
    Mallorca, Illes Balears, Spain
  • H. Manacor
    Manacor, Illes Balears, Spain
  • H. Santa Mª del Rosell
    Cartagena, Múrcia, Spain
  • H. de Arritxaca
    El Palmar, Múrcia, Spain
  • H. de Lorca
    Lorca, Múrcia, Spain
  • H. de Navarra
    Pamplona, Navarra, Spain
  • H. Basurto
    Bilbao, País Vasco, Spain
  • H. de Galdakano
    Bilbao, País Vasco, Spain
  • H. las Cruces
    Bilbao, País Vasco, Spain
  • H. de Donosti
    San Sebastián, País Vasco, Spain
  • Hospital del Mar
    Barcelona, Spain

Showing the first 100 of 104 sites.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01033045
Lead sponsor
Fundacion IMIM
Responsible party
Ricard Sola (MD, Fundacion IMIM) — Principal investigator
First posted
Dec 16, 2009
Start date
Sep 2009
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Feb 12, 2016

Study contacts

Ricard Solà Lamoglia, Dr.
principal investigator · Hospital del Mar
Ramón Planas Vila, Dr.
principal investigator · Hospital Germans Tries i Pujol, Barcelona
Javier García-Samaniego, Dr.
principal investigator · Hospital Carlos III, Madrid
Moisés Diago, Dr.
principal investigator · Hospital General Universitario de Valencia
Manuel Romero, Dr.
principal investigator · Hospital de Valme, Sevilla
José Luís Calleja, Dr
principal investigator · Hospital Puerta del Hierro, Madrid

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion