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Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6

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ClinicalTrials.gov Identifier: NCT03341871
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.

Condition or disease
Hepatitis C Virus (HCV)

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
Actual Study Start Date : December 27, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
HCV Genotypes 1, 2, 3, 4, 5, or 6 participants
Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to the current local label.



Primary Outcome Measures :
  1. Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after last dose of drug ]
    SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level < the lower limit of quantification (LLOQ) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir.


Secondary Outcome Measures :
  1. Percentage of Participants with Post-treatment Relapse [ Time Frame: Up to 24 weeks after last dose of drug ]
    Post-treatment relapse was defined as confirmed HCV RNA >= LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.

  2. Percentage of Participants with On-treatment Virologic Failure [ Time Frame: Up to 12 weeks after first dose ]
    On-treatment virologic failure was defined as HCV RNA levels reach < LLOQ during treatment then increase to >= LLOQ during treatment, or confirmed increase of > 1 log10 IU/mL above the lowest value post-baseline HCV RNA during treatment.

  3. Percentage of Participants Achieving SVR4 [ Time Frame: 4 weeks after last dose ]
    SVR4 defined as defined as the HCV RNA level < LLOQ 4 weeks after the last dose of Glecaprevir plus Pibrentasvir.

  4. Percentage of Participants Achieving SVR8 [ Time Frame: 8 weeks after last dose of drug ]
    SVR8 defined as defined as the HCV RNA level < LLOQ 8 weeks after the last dose of Glecaprevir plus Pibrentasvir.

  5. Percentage of Participants Achieving SVR24 [ Time Frame: 24 weeks after last dose of drug ]
    SVR24 defined as the HCV RNA level < LLOQ 24 weeks after the last dose of Glecaprevir plus Pibrentasvir.



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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japan patients infected with hepatitis C virus and treating with glecaprevir plus pibrentasvir per approved Japan label.
Criteria

Inclusion Criteria:

  • Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir.

Exclusion Criteria:

  • Patients previously treated with glecaprevir plus pibrentasvir.

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): NCT03341871


Contacts
Contact: AbbVie GK Clinical Trial Registration Desk +81-3-4577-1111 abbvie_jpn_info_clingov@abbvie.com

Locations
Japan
Abbvie Japan /ID# 161985 Recruiting
Tokyo, Japan, 108-6302
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03341871     History of Changes
Other Study ID Numbers: P16-570
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
chronic hepatitis C virus (HCV)
Genotype
glecaprevir
pibrentasvir
sustained virologic response
chronic hepatitis C virus genotype 1
chronic hepatitis C virus genotype 2
chronic hepatitis C virus genotype 3
chronic hepatitis C virus genotype 4
chronic hepatitis C virus genotype 5
chronic hepatitis C virus genotype 6

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