Phase 3
Completed N=295
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
Chronic Hepatitis C Virus · Hepatitis C
Source: ClinicalTrials.gov NCT02707952 ↗
Enrolled (actual)
295
Serious AEs
1.4%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants in Arms A and B With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 99.1; 100 percentage of participants
◆ Published Evidence
Highly cited
113citations · ~14 / year
Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection.
Summary
The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve, and DAA treatment-experienced Japanese adult subjects.
Linked Publications (5)
-
Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection.
-
Integrated Resistance Analysis of CERTAIN-1 and CERTAIN-2 Studies in Hepatitis C Virus-Infected Patients Receiving Glecaprevir and Pibrentasvir in Japan.
-
Hepatitis C virus testing for case identification in persons born during 1945-1965: Results from three randomized controlled trials.
-
Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection.
-
Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Arms A and B With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
99.1; 100 | — |
| SECONDARY Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
99.2 | — |
| SECONDARY Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
100; 100; 93.9; 83.3; 100.0; 100 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0; 0; 1.0; 0 | — |
| SECONDARY Percentage of Participants With Post-Treatment Relapse |
0; 0; 3.0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Females were postmenopausal for at least 2 years; surgically sterile or had a vasectomized partner; or, if of childbearing potential and sexually active with a male partner, were currently using at least 1 effective method of birth control at the time of Screening and agreed to practice 1 effective method of birth control from Screening through 30 days after stopping study drug. Sexually active males were surgically sterile or, if sexually active with a female partner of childbearing potential, agreed to practice 1 effective form of birth control from Screening through 30 days after stopping study drug.
- Screening central laboratory result indicated HCV single genotype infection for the appropriate treatment arm, without co-infection of any other genotype.
- Chronic HCV infection is defined as one of the following:
- Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before Screening.
- A liver biopsy consistent with chronic HCV infection.
- Agreed to voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study specific procedures.
- Participants who were able to understand and adhere to the study visit schedule and all other protocol requirements.
- Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI).
Exclusion Criteria
- Females who were pregnant or planned to become pregnant, or breastfeeding or males whose partner was pregnant or planning to become pregnant during the study.
- Participants co-infected with hepatitis B virus or human immunodeficiency virus.
- Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if known), whichever was longer, prior to the first dose of any study drug.
- 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.
- Any cause of liver disease other than chronic HCV infection.
- Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of decompensated liver disease.
- Consideration by the investigator, for any reason, that the participant is an unsuitable candidate to receive ABT-493/ABT-530.
Data sourced from ClinicalTrials.gov (NCT02707952) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.