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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

April 1, 2017
April 13, 2017
April 13, 2017
March 31, 2017
April 30, 2017   (Final data collection date for primary outcome measure)
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.

Same as current
No Changes Posted
  • 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.

Same as current
Not Provided
Not Provided
 
Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
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).
Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
8 Months
Not Provided
Non-Probability Sample
Patients with HCV who are treated in real practice with Elbasvir/Grazoprevir
Hepatitis C
Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
Spanish cohort with HCV treated with DAA
Intervention: Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
Same as current
November 30, 2017
April 30, 2017   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Marta Hernández Conde marta.hernandez.conde@gmail.com
Spain
 
 
NCT03111966
0001
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Hepa C
Hepa C
Not Provided
Not Provided
Hepa C
April 2017