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

February 7, 2019 updated by: Hepa C
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28020
        • HepaC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with HCV who are treated in real practice with Elbasvir/Grazoprevir

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spanish cohort with HCV treated with DAA
Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sustained virological response 12 weeks post-treatment (SVR12)
Time Frame: 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.
12 weeks after the last dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
virologic failure
Time Frame: 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
Up to 8 weeks while on treatment
SVR 12 and patients with mild fibrosis
Time Frame: 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
Up to 12 weeks after last dose of study drug
low baseline viral load and SVR12
Time Frame: 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.
Baseline and 12 weeks after the last dose of drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepa C

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2017

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

April 1, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Researcher)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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