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Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study (MAGELLAN-3)

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ClinicalTrials.gov Identifier: NCT02939989
Recruitment Status : Completed
First Posted : October 20, 2016
Results First Posted : May 4, 2022
Last Update Posted : May 4, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: Sofosbuvir Drug: Glecaprevir/Pibrentasvir Drug: Ribavirin Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Detailed Description:

This study enrolled HCV infected adults who had experienced virologic failure following treatment with glecaprevir/pibrentasvir or paritaprevir/ritonavir/ombitasvir + dasabuvir (DSV) (3D) or paritaprevir/ritonavir/ombitasvir (2D) regimens in one of the following AbbVie hepatitis C virus parent studies:

  • M13-594 (NCT02640157)
  • M13-596 (NCT02692703)
  • M14-172 (NCT02642432)
  • M14-242 (NCT02493855)
  • M14-868 (NCT02243293)
  • M15-410 (NCT02446717)
  • M15-592 (NCT03222583)
  • M16-126 (NCT02966795)
  • M16-135 (NCT03089944)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)
Actual Study Start Date : November 21, 2016
Actual Primary Completion Date : May 7, 2021
Actual Study Completion Date : July 30, 2021


Arm Intervention/treatment
Experimental: Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.
Drug: Sofosbuvir
Tablet for oral administration
Other Name: SOVALDI

Drug: Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Other Names:
  • ABT-493/ABT-530
  • MAVYRET
  • MAVIRET

Drug: Ribavirin
Tablet for oral administration

Experimental: Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
Drug: Sofosbuvir
Tablet for oral administration
Other Name: SOVALDI

Drug: Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Other Names:
  • ABT-493/ABT-530
  • MAVYRET
  • MAVIRET

Drug: Ribavirin
Tablet for oral administration




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen. ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.


Secondary Outcome Measures :
  1. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: 12 or 16 weeks depending on the treatment regimen ]

    On-treatment virologic failure was defined as meeting one of the following:

    • confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the treatment period; or
    • confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or
    • HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.

  2. Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen). ]
    Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.



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 to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects must be adults (18 years of age or older) or adolescents (12 to less than 18 years of age weighing at least 35 kg).
  • Subject must have experienced virologic failure during or after treatment with ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at AbbVie's discretion. Treatment in the parent study must have been completed or discontinued at least 1 month prior to the Screening Visit.
  • Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
  • Cirrhotic subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at Screening and no current or past evidence of Child-Pugh B or C Classification or no clinical history of liver decompensation, including ascites noted on physical exam, hepatic encephalopathy or esophageal variceal bleeding.
  • Cirrhotic subjects must have absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative US at Screening.

Exclusion Criteria:

  • History of severe, life-threatening or other clinically significant sensitivity to any study drug or drug component.
  • Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for 4 months after the last dose of study drug, or as directed per the local RBV label, whichever is more restrictive.
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg).
  • Screening laboratory analyses showing calculated creatinine clearance < 30 mL/min.
  • Discontinuation from the AbbVie HCV parent study for reasons other than virologic failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse event).
  • Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV parent study.

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): NCT02939989


Locations
Show Show 26 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] November 6, 2017
Statistical Analysis Plan  [PDF] July 28, 2020

Publications:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02939989    
Other Study ID Numbers: M15-942
2016-002491-26 ( EudraCT Number )
First Posted: October 20, 2016    Key Record Dates
Results First Posted: May 4, 2022
Last Update Posted: May 4, 2022
Last Verified: April 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 and 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, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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.: No
Keywords provided by AbbVie:
Chronic Hepatitis C (HCV)
HCV Genotype 1 (HCV GT1)
HCV Genotype 2 (HCV GT2)
HCV Genotype 3 (HCV GT3)
HCV Genotype 4 (HCV GT4)
HCV Genotype 5 (HCV GT5)
HCV Genotype 6 (HCV GT6)
Compensated Cirrhosis
Non-cirrhotics
Virologic failure
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents