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The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02581020
Recruitment Status : Active, not recruiting
First Posted : October 20, 2015
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.

Condition or disease
Hepatitis C Virus

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Study Type : Observational
Actual Enrollment : 345 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Follow-up Study to Assess the Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
Actual Study Start Date : January 14, 2016
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
1
Participants who were treated with 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow up from the prior Phase 2 or 3 studies conducted in Japan.



Primary Outcome Measures :
  1. Hepatitis C virus ribonucleic acid (HCV RNA) levels [ Time Frame: 60 months after completion of the 2D treatment in M12-536 or M13-004 study ]
    HCV RNA levels in plasma


Secondary Outcome Measures :
  1. Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3) [ Time Frame: For approximately 5 years ]
  2. Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A) [ Time Frame: For approximately 5 years ]
  3. Percentage of participants with hepatocellular carcinoma [ Time Frame: Up to 60 month after completion of the 2D treatment in M12-536 or M13-004 ]
  4. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study ]
    All serious adverse events will be monitored during the observation period.

  5. Hepatitis C virus ribonucleic acid (HCV RNA) levels [ Time Frame: 18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study ]
    HCV RNA levels in plasma



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who were treated in Study M12-536 or M13-004 with 2D regimen (ombitasvir/ paritaprevir/ritonavir) and completed 48 weeks of follow-up.
Criteria

Inclusion Criteria:

  • Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement.
  • Participants who agree to sign the informed consent

Exclusion Criteria:

  • Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.

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): NCT02581020


  Show 54 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02581020     History of Changes
Other Study ID Numbers: P15-349
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Hepatitis C
Follow-up
Observation
Japanese

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