Hepatitis CNCT02004379
Register of Telaprevir and Boceprevir in Routine Clinical Practice
An observational study of Hepatitis C, run by Fundación Pública Andaluza Progreso y Salud at 48 sites in Spain.
Trial summary
Know through routine clinical practice the effectiveness and safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- How many people
- 1,553 participants
- Where
- 48 sitesSpain
- Study dates
- Nov 2013to Jun 2015
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic hepatitis C, genotype 1, who are elegible to be treated with telaprevir or boceprevir
Who may be able to join
- Patients infected by hepatitis C virus, genotype 1
- Indication of treatment with telaprevir or boceprevir in F3 and F4 fibrosis
Who cannot join
- Being taking part in other
- Inability to follow a monitoring
- Contra-indications on triple therapy
- Coinfected with HIV and HBV (hepatitis B virus)
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
Spain48 sites
Hospital Universitario A Coruña
A Coruña
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid
Hospital de Poniente
Almería
Hospital Torrecárdenas
Almería
Hospital Infanta Cristina
Badajoz
Hospital Universitario de Cruces
Bilbao
Hospital San Pedro de Alcántara
Cáceres
Hospital Puerta del Mar
Cadiz
Hospital General de Ciudad Real
Ciudad Real
Hospital Reina Sofía
Córdoba
Hospital Universitario de San Cecilio
Granada
Hospital Universitario Virgen de las Nieves
Granada
Hospital de Guadalajara
Guadalajara
Hospital Juan Ramón Jiménez
Huelva
Hospital San Jorge
Huesca
Complejo Hospitalario de Jaén
Jaén
Hospital Universitario Doctor Negrín
Las Palmas de Gran Canaria, Gran Canaria
Hospital de León
León
Hospital General Universitario Rafael Méndez
Lorca, Murcia
Hospital Ramón y Cajal
Madrid
Hospital Universitario de La Princesa
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Carlos Haya
Málaga
Hospital Universitario Virgen de la Victoria
Málaga
Agencia Sanitaria Costa del Sol
Marbella, Málaga
Hospital Comarcal Santa Ana
Motril, Granada
Hospital Morales Meseguer
Murcia
Hospital Reina Sofía
Murcia
Hospital Universitario Virgen de la Arrixaca
Murcia
Hospital Universitario Central de Asturias
Oviedo
Hospital Son Espases
Palma de Mallorca, Mallorca
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario de Donostia
San Sebastián
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Tenerife
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña
Hospital Universitario de Valme
Seville
Hospital Universitario Virgen de la Macarena
Seville
Hospital Unviersitario Virgen del Rocío
Seville
Complejo Hospitalario de Toledo
Toledo
Hospital Arnau de Vilanova
Valencia
Hospital Clínico de Valencia
Valencia
Hospital General de Valencia
Valencia
Hospital la Fe
Valencia
Hospital Clínico Universitario de Valladolid
Valladolid
Hospital Universitario Río Hortega
Valladolid
Hospital de Zamora
Zamora
Hospital Clínico Universitario de Zaragoza
Zaragoza
Hospital Universitario Miguel Servet
Zaragoza
About this study
Know through routine clinical practice the effectiveness and safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
- Conditions
- Hepatitis C
- Keywords
- HCV, Hepatitis C, telaprevir, boceprevir, clinical practice
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hepatitis C, genotype 1 | Patients with hepatitis C, genotype 1, treated with telaprevir or boceprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
Know through routine clinical practice the percentage of patients who have negative VHC-ARN
Measured: 12 months
Safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
Number and frequencies of serious adverse event (SAE) during the treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 1,553 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Salmerón Escobar, Principal investigator, Hospital Universitario de San Cecilio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004379
- Sponsor's protocol ID
- FPS-TEL-2013-01
- Status last verified
- Jul 2015
- First submitted
- 20 Nov 2013
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Salmeron J, Vinaixa C, Berenguer R, Pascasio JM, Sanchez Ruano JJ, Serra MA, Gila A, Diago M, Romero-Gomez M, Navarro JM, Testillano M, Fernandez C, Espinosa D, Carmona I, Pons JA, Jorquera F, Rodriguez FJ, Perez R, Montero JL, Granados R, Fernandez M, Martin AB, Munoz de Rueda P, Quiles R; Alhambra Spanish Study Group. Effectiveness and safety of first-generation protease inhibitors in clinical practice: Hepatitis C virus patients with advanced fibrosis. World J Gastroenterol. 2015 Aug 14;21(30):9163-74. doi: 10.3748/wjg.v21.i30.9163.
PubMed 26290644
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register of Telaprevir and Boceprevir in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02004379
- Acronym / sponsor ID
- FPS-TEL-2013-01
- Conditions
- Hepatitis C
- Keywords
- HCV, Hepatitis C, telaprevir, boceprevir, clinical practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,553 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Know through routine clinical practice the effectiveness and safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
Study design
- Observational model
- Cohort
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hepatitis C, genotype 1 | – | –Patients with hepatitis C, genotype 1, treated with telaprevir or boceprevir |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic hepatitis C, genotype 1, who are elegible to be treated with telaprevir or boceprevir
Key inclusion criteria (2 listed)
- Patients infected by hepatitis C virus, genotype 1
- Indication of treatment with telaprevir or boceprevir in F3 and F4 fibrosis
Key exclusion criteria (4 listed)
- Being taking part in other
- Inability to follow a monitoring
- Contra-indications on triple therapy
- Coinfected with HIV and HBV (hepatitis B virus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
Time frame: 12 months
Know through routine clinical practice the percentage of patients who have negative VHC-ARN
Safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
Time frame: 12 months
Number and frequencies of serious adverse event (SAE) during the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Derived from this study: PubMed 26290644Salmeron J, Vinaixa C, Berenguer R, Pascasio JM, Sanchez Ruano JJ, Serra MA, Gila A, Diago M, Romero-Gomez M, Navarro JM, Testillano M, Fernandez C, Espinosa D, Carmona I, Pons JA, Jorquera F, Rodriguez FJ, Perez R, Montero JL, Granados R, Fernandez M, Martin AB, Munoz de Rueda P, Quiles R; Alhambra Spanish Study Group. Effectiveness and safety of first-generation protease inhibitors in clinical practice: Hepatitis C virus patients with advanced fibrosis. World J Gastroenterol. 2015 Aug 14;21(30):9163-74. doi: 10.3748/wjg.v21.i30.9163.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Salmerón Escobar principal investigator
Hospital Universitario de San Cecilio
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Fundación Pública Andaluza Progreso y Salud at 48 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 2 inclusion and 4 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 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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?
Effectiveness of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02004379, which also lists 1 linked publication.
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 15 Jul 2015.