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OpenTrials
Completed

NCT Number: NCT03111966

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

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).

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HepaC

Madrid, 28020, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

Other

Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Hepa C

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2017
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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