Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
1 other identifier
observational
130
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2017
CompletedFirst Submitted
Initial submission to the registry
April 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedFebruary 11, 2019
February 1, 2019
1 month
April 1, 2017
February 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sustained virological response 12 weeks post-treatment (SVR12)
Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12) • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.
12 weeks after the last dose of study drug
Secondary Outcomes (3)
virologic failure
Up to 8 weeks while on treatment
SVR 12 and patients with mild fibrosis
Up to 12 weeks after last dose of study drug
low baseline viral load and SVR12
Baseline and 12 weeks after the last dose of drug
Study Arms (1)
Spanish cohort with HCV treated with DAA
Interventions
Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
Eligibility Criteria
Patients with HCV who are treated in real practice with Elbasvir/Grazoprevir
You may qualify if:
- Age: 18 years to 100 years (adult).
- Sexes: all
- Healthy volunteers: no
- Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hepa Clead
Study Sites (1)
HepaC
Madrid, 28020, Spain
Related Publications (1)
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.
PMID: 30265418RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 8 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2017
First Posted
April 13, 2017
Study Start
March 31, 2017
Primary Completion
April 30, 2017
Study Completion
November 30, 2017
Last Updated
February 11, 2019
Record last verified: 2019-02