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

Completed

• Conditions: Hepatitis C
• Interventions: Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

• Registration Number: NCT03111966
• Lead Sponsor: Hepa C

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)

Study Timeline

• Study Start: 2017-03-31
• Study First Submitted: 2017-04-01
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-13
• Primary Completion: 2017-04-30
• Study Completion: 2017-11-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spanish cohort with HCV treated with DAA	Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir	-

Primary Outcome Measures

Name	Time	Method
sustained virological response 12 weeks post-treatment (SVR12)	12 weeks after the last dose of study drug	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.

Secondary Outcome Measures

Name	Time	Method
virologic failure	Up to 8 weeks while on treatment	Percentage of patients with virologic failure during treatment; • Measure: Percentage of patients with confirmed \>=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment or previous unquantifiable HCV up to 12 weeks after last dose of drug
low baseline viral load and SVR12	Baseline and 12 weeks after the last dose of drug	Percentage of participants with low baseline viral load who achieve sustained; • Measure: HCV RNA levels less than the lower limit of quantification.
SVR 12 and patients with mild fibrosis	Up to 12 weeks after last dose of study drug	Percentage of patients with mild fibrosis who achieve sustained virological response 12 (SVR12) weeks post-treatment; • Measure: percentage of patients with a baseline transient elastography \< 6 kPa

Trial Locations

Locations (1)

HepaC; 🇪🇸 Madrid, Spain