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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03222583
Other study ID # M15-592
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 4, 2017
Est. completion date February 15, 2019

Study information

Verified date November 2019
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.


Description:

Randomization was stratified by geographic region (China, South Korea, Singapore), genotype (GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected). In China, eligible participants were randomized to Arm A or Arm B (defined below) in the following ratios: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3-6. In South Korea and Singapore, eligible participants were randomized to Arm A or Arm B in the following ratios: 2:1 for GT1 and 2:1 for GT2.

All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A.


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Study Design


Intervention

Drug:
Placebo
Matching placebo tablet for oral administration
Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration

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Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

China,  Korea, Republic of,  Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12) Sustained virologic response 12 weeks post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug. 12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
Primary Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12 SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug. 12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen
Primary Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12 SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last actual dose of study drug. 12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
Secondary Percentage of Participants in Arm A 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.
8 or 16 weeks depending on the treatment regimen
Secondary Percentage of Participants in Arm A 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, excluding re-infection. From the end of treatment (Weeks 8 or 16) through 12 weeks after the last dose of study drug (Weeks 20 or 28 depending on the treatment regimen).
Secondary Percentage of HCV/HIV Co-infected Participants in Arm A Who Achieved SVR12 SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug. 12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen
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