Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort

NCT ID: NCT03111966

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2017-11-30

Brief Summary

This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).

Detailed Description

This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases)

Conditions

Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Spanish cohort with HCV treated with DAA

Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

Intervention Type: OTHER

Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

Interventions

Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age: 18 years to 100 years (adult).
• Sexes: all
• Healthy volunteers: no
• Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hepa C

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HepaC

Madrid, , Spain

Countries

Spain

References

Hernandez-Conde M, Fernandez I, Perello C, Gallego A, Bonacci M, Pascasio JM, Romero-Gomez M, Llerena S, Fernandez-Rodriguez C, Castro Urda JL, Garcia Buey L, Carmona I, Morillas RM, Garcia ND, Gea F, Carrion JA, Castellote J, Moreno-Planas JM, Piqueras Alcol B, Molina E, Diago M, Montoliu S, de la Vega J, Menendez F, Sanchez Ruano JJ, Garcia-Samaniego J, Rosales-Zabal JM, Anton MD, Badia E, Souto-Rodriguez R, Salmeron FJ, Fernandez-Bermejo M, Figueruela B, Moreno-Palomares JJ, Calleja JL. Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA-C real-world cohort. J Viral Hepat. 2019 Jan;26(1):55-64. doi: 10.1111/jvh.13008. Epub 2018 Oct 25.

Reference Type: RESULT

PMID: 30265418 (View on PubMed)

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id