Hepatitis C
Conditions
Keywords
Hepatitis 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)
Interventions
OTHERSpanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
Sponsors
Hepa C
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
Spain
Outcome results
None listed