Back to resultsEfficacy 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)
Primary Purpose
Hepatitis C Virus Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sofosbuvir
Glecaprevir/Pibrentasvir
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring 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
Eligibility 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.
Sites / Locations
- Digestive Health Specialists of the Southeast /ID# 155719
- Ruane Clinical Research Group /ID# 155714
- Digestive Disease Associates - Baltimore /ID# 155713
- Henry Ford Health System /ID# 155720
- University of Buffalo /ID# 155721
- Carolinas Center For Liver Dis /ID# 155731
- Gastro One /ID# 155729
- TX Liver Inst, Americ Res Corp /ID# 157881
- Royal Brisbane and Women's Hospital /ID# 200944
- The Royal Melbourne Hospital /ID# 155727
- University of Calgary /ID# 155726
- Beijing Di Tan Hospital, Capital Medical University /ID# 218496
- West China Hospital, Sichuan University /ID# 217613
- The First Hospital Affiliated to AMU (Southwest Hospital) /ID# 218494
- Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 218495
- Zentru fur HIV und Heaptogastroenterologie /ID# 155592
- Asklepios Klinik St. Georg /ID# 155733
- Samsung Medical Center /ID# 214844
- Auckland City Hospital /ID# 200945
- Waikato Hospital /ID# 155728
- Dunedin Hospital /ID# 155591
- Medical Company Hepatolog /ID# 214314
- Hospital Universitario Puerta de Hierro, Majadahonda /ID# 155734
- Duplicate_Karolinska Univ Sjukhuset /ID# 155735
- Inselspital, Universitätsspital Bern /ID# 155716
- Duplicate_Imperial College Healthcare NHS Trust /ID# 155718
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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
Percentage of Participants With On-treatment Virologic Failure
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.
Percentage of Participants With Post-treatment Relapse
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02939989
Brief Title
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
Acronym
MAGELLAN-3
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2016 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
Arm Type
Experimental
Arm Description
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.
Arm Title
Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
SOVALDI
Intervention Description
Tablet for oral administration
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/Pibrentasvir
Other Intervention Name(s)
ABT-493/ABT-530, MAVYRET, MAVIRET
Intervention Description
Coformulated tablet for oral administration
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
Tablet for oral administration
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Description
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.
Time Frame
12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
Secondary Outcome Measure Information:
Title
Percentage of Participants With On-treatment Virologic Failure
Description
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.
Time Frame
12 or 16 weeks depending on the treatment regimen
Title
Percentage of Participants With Post-treatment Relapse
Description
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.
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialists of the Southeast /ID# 155719
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Ruane Clinical Research Group /ID# 155714
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Digestive Disease Associates - Baltimore /ID# 155713
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Henry Ford Health System /ID# 155720
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Buffalo /ID# 155721
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Carolinas Center For Liver Dis /ID# 155731
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Gastro One /ID# 155729
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
TX Liver Inst, Americ Res Corp /ID# 157881
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Royal Brisbane and Women's Hospital /ID# 200944
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
The Royal Melbourne Hospital /ID# 155727
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
University of Calgary /ID# 155726
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Beijing Di Tan Hospital, Capital Medical University /ID# 218496
City
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 217613
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The First Hospital Affiliated to AMU (Southwest Hospital) /ID# 218494
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 218495
City
Fuzhou
ZIP/Postal Code
350025
Country
China
Facility Name
Zentru fur HIV und Heaptogastroenterologie /ID# 155592
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40237
Country
Germany
Facility Name
Asklepios Klinik St. Georg /ID# 155733
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Samsung Medical Center /ID# 214844
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Auckland City Hospital /ID# 200945
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Waikato Hospital /ID# 155728
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Dunedin Hospital /ID# 155591
City
Otago
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Medical Company Hepatolog /ID# 214314
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443063
Country
Russian Federation
Facility Name
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 155734
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Duplicate_Karolinska Univ Sjukhuset /ID# 155735
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
Inselspital, Universitätsspital Bern /ID# 155716
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Duplicate_Imperial College Healthcare NHS Trust /ID# 155718
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
30857780
Citation
Wyles D, Weiland O, Yao B, Weilert F, Dufour JF, Gordon SC, Stoehr A, Brown A, Mauss S, Zhang Z, Pilot-Matias T, Rodrigues L Jr, Mensa FJ, Poordad F. Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection. J Hepatol. 2019 May;70(5):1019-1023. doi: 10.1016/j.jhep.2019.01.031. Epub 2019 Mar 8. No abstract available.
Results Reference
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Learn more about this trial
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
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