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Trial record 25 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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 : Completed
First Posted : April 13, 2017
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hepa C

Tracking Information
First Submitted Date April 1, 2017
First Posted Date April 13, 2017
Last Update Posted Date February 11, 2019
Actual Study Start Date March 31, 2017
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03111966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 11, 2017)
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
Official Title Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
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)
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 8 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with HCV who are treated in real practice with Elbasvir/Grazoprevir
Condition 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
Study Groups/Cohorts Spanish cohort with HCV treated with DAA
Intervention: Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
Publications * 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 Alcol B, Molina E, Diago M, Montoliu S, de la Vega J, Menéndez F, Sánchez Ruano JJ, García-Samaniego J, Rosales-Zabal JM, Anton MD, Badia E, Souto-Rodríguez R, Salmeron FJ, Fernández-Bermejo M, Figueruela B, Moreno-Palomares JJ, Calleja JL. Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA-C real-world cohort. J Viral Hepat. 2019 Jan;26(1):55-64. doi: 10.1111/jvh.13008. Epub 2018 Oct 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 11, 2017)
130
Original Estimated Enrollment Same as current
Actual Study Completion Date November 30, 2017
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Eligibility 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:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03111966
Other Study ID Numbers 0001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hepa C
Study Sponsor Hepa C
Collaborators Not Provided
Investigators Not Provided
PRS Account Hepa C
Verification Date February 2019