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A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)

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ClinicalTrials.gov Identifier: NCT02692703
Recruitment Status : Completed
First Posted : February 26, 2016
Results First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C
HCV
Hepatitis C Virus
Intervention Drug: glecaprevir/pibrentasvir
Enrollment 100
Recruitment Details  
Pre-assignment Details The study included a 36-day screening period.
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Period Title: Overall Study
Started 100
Completed 98
Not Completed 2
Reason Not Completed
Lost to Follow-up             1
Not Specified             1
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
59.19  (7.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
25
  25.0%
Male
75
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Hispanic or Latino
17
  17.0%
Not Hispanic or Latino
83
  83.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
American Indian or Alaska Native
0
   0.0%
Asian
10
  10.0%
Native Hawaiian or Other Pacific Islander
3
   3.0%
Black or African American
8
   8.0%
White
78
  78.0%
More than one race
1
   1.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Hide Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 compared with the historical SVR12 rate for the current standard of care regimens (sofosbuvir [SOF]/ledipasvir [LDV] + ribavirin [RBV] OR SOF + daclatasvir [DCV] + RBV). Participants with missing data after backward imputation were counted as non-responders.
Time Frame 12 weeks after the last dose of study drug (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description:
Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Overall Number of Participants Analyzed 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98
(95.3 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glecaprevir/Pibrentasvir
Comments Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96%, 90 participants provides >90% power to demonstrate noninferiority of the regimen to the historical rate for current standard of care regimens (SOF/LDV + RBV OR SOF + DCV + RBV) (94%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).
Type of Statistical Test Non-Inferiority
Comments The noninferiority of the rate of sustained virologic response at 12 weeks after treatment as compared with the historical rate for the current standard of care regimens (SOF/LDV + RBV or SOF + DCV + RBV) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 86% to achieve noninferiority.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 98
Confidence Interval (2-Sided) 95%
95.3 to 100.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure
Hide Description On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description:
Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse
Hide Description 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.
Time Frame From the end of treatment through 12 weeks after the last dose of study drug (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug, completed treatment, had HCV RNA <LLOQ at the final treatment visit, and had post-treatment data available, excluding reinfection.
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description:
Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: percentage of participants
1
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
Adverse Event Reporting Description TEAEs and SAEs are defined as any AE or SAE that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
 
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
All-Cause Mortality
Glecaprevir/Pibrentasvir
Affected / at Risk (%)
Total   0/100 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Glecaprevir/Pibrentasvir
Affected / at Risk (%) # Events
Total   8/100 (8.00%)    
Blood and lymphatic system disorders   
Neutropenia  1  1/100 (1.00%)  1
Congenital, familial and genetic disorders   
Arteriovenous malformation  1  1/100 (1.00%)  1
Infections and infestations   
Groin infection  1  1/100 (1.00%)  1
Hepatitis E  1  1/100 (1.00%)  1
Pneumonia  1  1/100 (1.00%)  1
Pyelonephritis  1  1/100 (1.00%)  2
Respiratory tract infection  1  1/100 (1.00%)  1
Sepsis  1  2/100 (2.00%)  3
Sinusitis  1  1/100 (1.00%)  1
Urinary tract infection  1  1/100 (1.00%)  2
Injury, poisoning and procedural complications   
Vascular pseudoaneurysm ruptured  1  1/100 (1.00%)  1
Investigations   
Immunosuppressant drug level increased  1  1/100 (1.00%)  1
Liver function test increased  1  1/100 (1.00%)  1
Nervous system disorders   
Cerebrovascular accident  1  1/100 (1.00%)  1
Renal and urinary disorders   
Renal failure  1  1/100 (1.00%)  1
Renal impairment  1  2/100 (2.00%)  2
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glecaprevir/Pibrentasvir
Affected / at Risk (%) # Events
Total   67/100 (67.00%)    
Gastrointestinal disorders   
Abdominal pain upper  1  5/100 (5.00%)  5
Diarrhoea  1  10/100 (10.00%)  11
Nausea  1  12/100 (12.00%)  13
Vomiting  1  5/100 (5.00%)  8
General disorders   
Fatigue  1  22/100 (22.00%)  26
Infections and infestations   
Upper respiratory tract infection  1  8/100 (8.00%)  10
Urinary tract infection  1  5/100 (5.00%)  6
Viral upper respiratory tract infection  1  8/100 (8.00%)  10
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/100 (7.00%)  7
Pain in extremity  1  5/100 (5.00%)  7
Nervous system disorders   
Dizziness  1  6/100 (6.00%)  7
Headache  1  22/100 (22.00%)  26
Psychiatric disorders   
Insomnia  1  6/100 (6.00%)  6
Respiratory, thoracic and mediastinal disorders   
Cough  1  9/100 (9.00%)  9
Skin and subcutaneous tissue disorders   
Pruritus  1  12/100 (12.00%)  13
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02692703     History of Changes
Other Study ID Numbers: M13-596
2015-005616-14 ( EudraCT Number )
First Submitted: February 23, 2016
First Posted: February 26, 2016
Results First Submitted: March 8, 2018
Results First Posted: April 4, 2018
Last Update Posted: April 4, 2018