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AzTrials

Hepatitis CNCT01033045

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

An observational study of Hepatitis C, run by Fundacion IMIM at 104 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
How many people
2,178 participants
Where
104 sitesSpain
Study dates
Sep 2009to Jul 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

104 sites in 1 country.

104 sites in 1 country

Spain104 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, Galicia

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, Galicia

  • H. de Albacete

    Albacete, Castille-La Mancha

  • H. de Henares

    Alcalá de Henares, C. de Madrid

  • Fundación de Alcorcón

    Alcorcón, C. de Madrid

  • H. de Alcoy

    Alcoy, C. Valenciana

  • H. General de Alicante

    Alicante, C. Valenciana

  • H. Marina Baixa

    Alicante, C. Valenciana

  • H. de Antequera

    Antequera, Andalusia

  • H. Infanta Cristina

    Badajoz, Extremadura

  • H. Germans Trias Pujol

    Badalona, Catalonia

  • Hospital del Mar

    Barcelona, Barcelona

  • H. Clínic

    Barcelona, Catalonia

  • H. Sant Boi

    Barcelona, Catalonia

  • H. Sant Pau

    Barcelona, Catalonia

  • Hospital de Bellvitge

    Barcelona, Catalonia

  • H. Basurto

    Bilbao, Basque Country

  • H. de Galdakano

    Bilbao, Basque Country

  • H. las Cruces

    Bilbao, Basque Country

  • H. San Pedro Alcántara

    Cáceres, Extremadura

  • H. Puerta de Mar

    Cadiz, Andalusia

  • H. Puerto Real

    Cadiz, Andalusia

  • H. Santa Mª del Rosell

    Cartagena, Murcia

  • H. de Castellón

    Castellon, C. Valenciana

  • H. Ciudad Real

    Ciudad Real, Castille-La Mancha

  • H. de Coria/Plasencia

    Coria, Extremadura

  • H. de Cuenca

    Cuenca, Castille-La Mancha

  • H. de Donosti

    Donostia / San Sebastian, Basque Country

  • H. de Arritxaca

    El Palmar, Murcia

  • Xarxa Sanitaria i Social de Santa Tecla (Tarragona)

    El Vendrell, Catalonia

  • H. de Elche

    Elche, C. Valenciana

  • H. Arquitecto Marcide

    Ferrol, Galicia

  • H. de Figueres

    Figueres, Catalonia

  • H. de Getafe

    Getafe, C. de Madrid

  • H. Josep Trueta

    Girona, Catalonia

  • H. Santa Caterina

    Girona, Catalonia

  • H. Insular

    Gran Canaria, Canary Islands

  • H. Vírgen de las Nieves

    Granada, Andalusia

  • H. Infanta Elena

    Huelva, Andalusia

  • H. San Jorge

    Huesca, Aragon

  • H. General de Igualada

    Igualada, Catalonia

  • H. de Jaen

    Jaén, Andalusia

  • H. de Jerez

    Jerez de la Frontera, Andalusia

  • H. Dr. José Molina Orrosos

    Lanzarote, Canary Islands

  • H. de León

    León, Castille and León

  • H. de Lorca

    Lorca, Murcia

  • H. Carlos III

    Madrid, C de Madrid

  • H. 12 de Octubre

    Madrid, C. de Madrid

  • H. Fundación Jiménez Díaz

    Madrid, C. de Madrid

  • H. la Paz

    Madrid, C. de Madrid

  • H. la Princesa

    Madrid, C. de Madrid

  • H. Príncipe de Astúrias

    Madrid, C. de Madrid

  • H. Severo Ochoa

    Madrid, C. de Madrid

  • H. Puerta del Hierro

    Madrid, Madrid

  • H. Carlos Haya

    Málaga, Andalusia

  • H. Vírgen de la Victoria

    Málaga, Andalusia

  • H. Son Dureta

    Mallorca, Balearic Islands

  • H. Son Llàtzer

    Mallorca, Balearic Islands

  • H. Manacor

    Manacor, Balearic Islands

  • H. Sant Joan de Déu de Manresa

    Manresa, Catalonia

  • H. de Manzanares

    Manzanares, Castille-La Mancha

  • H. Sant Joan de Déu de Martorell

    Martorell, Catalonia

  • H. de Mérida

    Mérida, Extremadura

  • H. de Móstoles

    Móstoles, C. de Madrid

  • H. General de Múrcia

    Murcia, Murcia

  • H. Morales Messeguer

    Murcia, Murcia

  • H. Vega Baja

    Orihuela, C. Valenciana

  • Complexo Hospitalario Ourense

    Ourense, Galicia

  • H. Central de Astúrias

    Oviedo, Principality of Asturias

  • H. de Navarra

    Pamplona, Navarre

  • H. Infanta Cristina

    Parla, C. de Madrid

  • H. Comarcal el Bierzo

    Ponferrada, Castille and León

  • Complexo Hospitalario Pontevedra

    Pontevedra, Galicia

  • H. Sant Joan de Reus

    Reus, Catalonia

  • H. Parc Taulí de Sabadell

    Sabadell, Catalonia

  • H. Clínico de Salamanca

    Salamanca, Castille and León

  • H. Infanta Sofía

    San Sebastián de los Reyes, C. de Madrid

  • H. Esperit Sant

    Santa Coloma de Gramanet, Catalonia

  • H. Candelaria

    Santa Cruz de Tenerife, Canary Islands

  • H. Dr. Negrín

    Santa Cruz de Tenerife, Canary Islands

  • H. Universitario de Tenerife

    Santa Cruz de Tenerife, Canary Islands

  • H. de Valdecilla

    Santander, Cantabria

  • Complexo Hospitalario Universitario de Santiago

    Santiago de Compostela, Galicia

  • H. de Valme

    Seville, Andalusia

  • H. Vírgen del Rocío

    Seville, Sevilla

  • H. Joan XXIII

    Tarragona, Catalonia

  • H. Alcázar

    Toledo, Castille-La Mancha

  • H. Vírgen de la Salud

    Toledo, Castille-La Mancha

  • H, de Tomelloso

    Tomelloso, Castille-La Mancha

  • H. Verge de la Cinta de Tortosa

    Tortosa, Catalonia

  • H. de Valdepeñas

    Valdepeñas, Castille-La Mancha

  • H. Clínico de Valencia

    Valencia, C. Valenciana

  • H. General de Valencia

    Valencia, C. Valenciana

  • H. Clinico de Valladolid

    Valladolid, Castille and León

  • H. Río Ortega

    Valladolid, Castille and León

  • H. General de Vic

    Vic, Catalonia

  • Complejo hospitalario Vigo

    Vigo, Galicia

  • H. Meixoeiro

    Vigo, Galicia

  • H. Xeral Cíes

    Vigo, Galicia

  • POVISA

    Vigo, Galicia

  • H. de Viladecans

    Viladecans, Catalonia

  • H. de Xàtiva

    Xàtiva, C. Valenciana

  • H. Clínico de Zaragoza

    Zaragoza, Aragon

  • H. Miquel Servet

    Zaragoza, Aragon

Other trials in Spain

About this study

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

Conditions
Hepatitis C
Keywords
Hepatitis C, Viral, Non-A, Non-B, Parenterally-Transmitted
Medical subject headings
Hepatitis C

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 years

Secondary outcomes (7)

  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.

    Measured: 6 years

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 6

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

    Measured: 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
2,178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01033045
Sponsor's protocol ID
AGORA
Status last verified
Feb 2016
First submitted
15 Dec 2009
Last updated
12 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, run by Fundacion IMIM at 104 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe the management of patients with chronic hepatitis C and previous treatment failure (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01033045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.

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