Hepatitis C Clinical Trial
Official title:
Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure
| Verified date | February 2016 |
| Source | Fundacion IMIM |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to describe the management of patients with chronic hepatitis C and previous treatment failure.
| Status | Completed |
| Enrollment | 2178 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Complejo Hospitalario Universitario A Coruña | A Coruña | Galicia |
| Spain | Complexo Hospitalario Universitario A Coruña | A Coruña | Galicia |
| Spain | H. de Albacete | Albacete | Castilla la Mancha |
| Spain | H. de Henares | Alcalá de Henares | C. de Madrid |
| Spain | Fundación de Alcorcón | Alcorcón | 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 Antequera | Antequera | Andalucía |
| Spain | H. Infanta Cristina | Badajoz | Extremadura |
| 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 | Hospital del Mar | Barcelona | |
| Spain | H. Basurto | Bilbao | País Vasco |
| Spain | H. de Galdakano | Bilbao | País Vasco |
| Spain | H. las Cruces | Bilbao | País Vasco |
| Spain | H. San Pedro Alcántara | Cáceres | Extremadura |
| Spain | H. Puerta de Mar | Cádiz | Andalucía |
| Spain | H. Puerto Real | Cádiz | Andalucía |
| Spain | H. Santa Mª del Rosell | Cartagena | Múrcia |
| Spain | H. de Castellón | Castellón | C. Valenciana |
| Spain | H. Ciudad Real | Ciudad Real | Castilla la Mancha |
| Spain | H. de Coria/Plasencia | Coria | Extremadura |
| Spain | H. de Cuenca | Cuenca | Castilla la Mancha |
| Spain | H. de Arritxaca | El Palmar | Múrcia |
| Spain | Xarxa Sanitaria i Social de Santa Tecla (Tarragona) | El Vendrell | Cataluña |
| Spain | H. de Elche | Elche | C. Valenciana |
| Spain | H. Arquitecto Marcide | Ferrol | Galicia |
| Spain | H. de Figueres | Figueres | Cataluña |
| Spain | H. de Getafe | Getafe | C. de Madrid |
| Spain | H. Josep Trueta | Girona | Cataluña |
| Spain | H. Santa Caterina | Girona | Cataluña |
| Spain | H. Insular | Gran Canaria | Canarias |
| Spain | H. Vírgen de las Nieves | Granada | Andalucía |
| Spain | H. Infanta Elena | Huelva | Andalucía |
| Spain | H. San Jorge | Huesca | Aragón |
| Spain | H. General de Igualada | Igualada | Cataluña |
| Spain | H. de Jaen | Jaen | Andalucía |
| Spain | H. de Jerez | Jerez de la Frontera | Andalucía |
| Spain | H. Dr. José Molina Orrosos | Lanzarote | Canarias |
| Spain | H. de León | León | Castilla y León |
| Spain | H. de Lorca | Lorca | Múrcia |
| Spain | H. 12 de Octubre | Madrid | C. de Madrid |
| Spain | H. Carlos III | 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. Puerta del Hierro | Madrid | |
| Spain | H. Severo Ochoa | Madrid | C. de Madrid |
| Spain | H. Carlos Haya | Málaga | Andalucía |
| Spain | H. Vírgen de la Victoria | Málaga | Andalucía |
| Spain | H. Son Dureta | Mallorca | Illes Balears |
| Spain | H. Son Llàtzer | Mallorca | Illes Balears |
| Spain | H. Manacor | Manacor | Illes Balears |
| Spain | H. Sant Joan de Déu de Manresa | Manresa | Cataluña |
| Spain | H. de Manzanares | Manzanares | Castilla la Mancha |
| Spain | H. Sant Joan de Déu de Martorell | Martorell | Cataluña |
| Spain | H. de Mérida | Mérida | Extremadura |
| Spain | H. de Móstoles | Móstoles | C. de Madrid |
| Spain | H. General de Múrcia | Múrcia | |
| Spain | H. Morales Messeguer | Múrcia | |
| Spain | H. Vega Baja | Orihuela | C. Valenciana |
| Spain | Complexo Hospitalario Ourense | Ourense | Galicia |
| Spain | H. Central de Astúrias | Oviedo | Astúrias |
| Spain | H. de Navarra | Pamplona | Navarra |
| Spain | H. Infanta Cristina | Parla | C. de Madrid |
| Spain | H. Comarcal el Bierzo | Ponferrada | Castilla y León |
| Spain | Complexo Hospitalario Pontevedra | Pontevedra | Galicia |
| Spain | H. Sant Joan de Reus | Reus | Cataluña |
| Spain | H. Parc Taulí de Sabadell | Sabadell | Cataluña |
| Spain | H. Clínico de Salamanca | Salamanca | Castilla y León |
| Spain | H. de Donosti | San Sebastián | País Vasco |
| Spain | H. Infanta Sofía | San Sebastian de los Reyes | C. de Madrid |
| Spain | H. Esperit Sant | Santa Coloma de Gramanet | Cataluña |
| Spain | H. de Valdecilla | Santander | Cantabria |
| Spain | Complexo Hospitalario Universitario de Santiago | Santiago de Compostela | Galicia |
| Spain | H. de Valme | Sevilla | Andalucía |
| Spain | H. Vírgen del Rocío | Sevilla | |
| Spain | H. Joan XXIII | Tarragona | Cataluña |
| Spain | H. Candelaria | Tenerife | Canarias |
| Spain | H. Dr. Negrín | Tenerife | Canarias |
| Spain | H. Universitario de Tenerife | Tenerife | Canarias |
| 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. Verge de la Cinta de Tortosa | Tortosa | Cataluña |
| Spain | H. de Valdepeñas | Valdepeñas | Castilla la Mancha |
| Spain | H. Clínico de Valencia | Valencia | C. Valenciana |
| Spain | H. General de Valencia | Valencia | C. Valenciana |
| Spain | H. Clinico de Valladolid | Valladolid | Castilla y León |
| Spain | H. Río Ortega | Valladolid | Castilla y León |
| Spain | H. General de Vic | Vic | Cataluña |
| Spain | Complejo hospitalario Vigo | Vigo | Galicia |
| Spain | H. Meixoeiro | Vigo | Galicia |
| Spain | H. Xeral Cíes | Vigo | Galicia |
| Spain | POVISA | Vigo | Galicia |
| Spain | H. de Viladecans | Viladecans | Cataluña |
| Spain | H. de Xàtiva | Xàtiva | C. Valenciana |
| Spain | H. Clínico de Zaragoza | Zaragoza | Aragón |
| Spain | H. Miquel Servet | Zaragoza | Aragón |
| Lead Sponsor | Collaborator |
|---|---|
| Fundacion IMIM |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Describe the management of patients with chronic hepatitis C and previous treatment failure | 6 years | ||
| Secondary | 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. | 6 years | ||
| Secondary | To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes. | 6 years | ||
| Secondary | 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. | 6 years | ||
| Secondary | To know the causes of the dose modifications and withdrawal of treatment during the follow-up period in patients who start re-treatment. | 6 years | ||
| Secondary | To know the percentage of patients that achieve sustained viral response when implementing the recommendations based on the cause of the previous therapeutic failure. | 6 years | ||
| Secondary | 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-a/RBV. Patients with this polymorphism clear the virus more easily. | 6 | |
| Secondary | Compare the management of patients with chronic hepatitis C prior treatment failure before and after the appearance of new treatments. | 3 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Recruiting |
NCT04510246 -
Link Hepatitis C Notifications to Treatment in Tasmania
|
N/A | |
| Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
| Completed |
NCT03109457 -
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
|
||
| Completed |
NCT03118674 -
Harvoni Treatment Porphyria Cutanea Tarda
|
Phase 2 | |
| Completed |
NCT01458054 -
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
|
Phase 1 | |
| Completed |
NCT03740230 -
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
|
||
| Completed |
NCT03426787 -
Helping Empower Liver and Kidney Patients
|
N/A | |
| Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
| Completed |
NCT00006301 -
Immune Response to Hepatitis C Virus
|
||
| Active, not recruiting |
NCT03949764 -
The Kentucky Viral Hepatitis Treatment Study
|
Phase 4 | |
| Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
| Recruiting |
NCT04405024 -
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
|
N/A | |
| Completed |
NCT04525690 -
Improving Inpatient Screening for Hepatitis C
|
N/A | |
| Completed |
NCT04033887 -
Evaluation Study of RDTs Detecting Antibodies Against HCV
|
||
| Withdrawn |
NCT04546802 -
HepATocellular Cancer Hcv Therapy Study
|
Phase 3 | |
| Active, not recruiting |
NCT02961426 -
Strategic Transformation of the Market of HCV Treatments
|
Phase 2/Phase 3 | |
| Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
| Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 | |
| Completed |
NCT03186313 -
A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection
|
Phase 3 |