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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111966
• Other study ID #: 0001
• Status: Completed
• Start date: March 31, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: February 2019
• Source: Hepa C
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Other:
• Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

Locations

Country	Name	City	State
Spain	HepaC	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hepa C

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Hernández-Conde M, Fernández I, Perelló C, Gallego A, Bonacci M, Pascasio JM, Romero-Gómez M, Llerena S, Fernández-Rodríguez C, Castro Urda JL, García Buey L, Carmona I, Morillas RM, García ND, Gea F, Carrión JA, Castellote J, Moreno-Planas JM, Piqueras A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	virologic failure	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	Up to 8 weeks while on treatment
Secondary	SVR 12 and patients with mild fibrosis	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	Up to 12 weeks after last dose of study drug
Secondary	low baseline viral load and SVR12	Percentage of participants with low baseline viral load who achieve sustained; • Measure: HCV RNA levels less than the lower limit of quantification.	Baseline and 12 weeks after the last dose of drug