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Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

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ClinicalTrials.gov Identifier: NCT04903626
Recruitment Status : Recruiting
First Posted : May 26, 2021
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.

GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide.

Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.


Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Drug: Glecaprevir/Pibrentasvir (GLE/PIB) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 283 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection
Actual Study Start Date : August 24, 2021
Estimated Primary Completion Date : April 5, 2024
Estimated Study Completion Date : April 5, 2024


Arm Intervention/treatment
Experimental: Participants Treated With Glecaprevir/Pibrentasvir for 8 weeks
Participants treated once daily with oral tablets of glecaprevir/pibrentasvir for 8 weeks.
Drug: Glecaprevir/Pibrentasvir (GLE/PIB)
Oral tablets
Other Names:
  • ABT-493/ABT-530
  • Mavyret




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virological Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population [ Time Frame: 12 weeks after last dose of study drug (Week 20) ]
    SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) in the Modified ITT-Virologic Failure (mITT-VF) Population. [ Time Frame: 12 weeks after last dose of study drug (Week 20) ]
    SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.

  2. Percentage of Participants With On-Treatment Virologic Failure in the ITT Population [ Time Frame: Up to week 8 ]
    On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.

  3. Percentage of Participants With Post-Treatment Relapse in the ITT Population [ Time Frame: Up to 12 weeks after the last dose of study drug (Week 20) ]
    Post-treatment (PT) relapse is defined as confirmed HCV RNA >= LLOQ between the end of treatment (EOT) and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.

  4. Percentage of Participants With Post-Treatment Reinfection With HCV in the ITT Population [ Time Frame: Up to 12 weeks after the last dose of study drug (Week 20) ]
    Post-treatment (PT) reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of acute Hepatitis C Virus (HCV) infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV RNA at screening, and at least 1 of the following:

    • Negative anti-HCV antibody, HCV Ribonucleic Acid (RNA) and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; OR
    • Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
    • Clinical signs and symptoms compatible with acute hepatitis [Alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN) and/or jaundice] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
    • Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to screening.
  • Absence of hepatocellular carcinoma (HCC), for participants with cirrhosis, or with indeterminate cirrhosis status, as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or a negative ultrasound at screening. Participant who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
  • Participants documented as having no cirrhosis or as having compensated cirrhosis.

Exclusion Criteria:

  • Participants with prior treatment, including interferon for this HCV infection.
  • History of liver decompensation.

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): NCT04903626


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Show Show 63 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04903626    
Other Study ID Numbers: M20-350
2020-005777-27 ( EudraCT Number )
First Posted: May 26, 2021    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Acute HCV Infection
HCV Genotype 1-6
Hepatitis C
Glecaprevir/Pibrentasvir
ABT-493/ABT-530
Mavyret
Additional relevant MeSH terms:
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Infections
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections