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

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ClinicalTrials.gov Identifier: NCT03111966
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Hepatitis C Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir

Study Type : Observational [Patient Registry]
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Months
Official Title: Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : April 30, 2017
Estimated Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HCV who are treated in real practice with Elbasvir/Grazoprevir
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111966


Contacts
Contact: Marta Hernández Conde marta.hernandez.conde@gmail.com

Locations
Spain
HepaC Recruiting
Madrid, Spain, 28020
Contact: Marta Hernández Conde    0034679611532    marta.hernandez.conde@gmail.com   
Sponsors and Collaborators
Hepa C

Responsible Party: Hepa C
ClinicalTrials.gov Identifier: NCT03111966     History of Changes
Other Study ID Numbers: 0001
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hepa C:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections