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Phase 3 Completed N=136 Randomized Treatment

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection

Chronic Hepatitis C Virus · Hepatitis C
Source: ClinicalTrials.gov NCT02723084 ↗
Enrolled (actual)
136
Serious AEs
2.9%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Non-inferiority of Arm A to Arm B — 97.8; 93.5 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.
Hepatology (Baltimore, Md.) · 2018 · Open access · Likely link

Summary

The purpose of this phase 3 study is to evaluate the efficacy and safety of ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12 weeks in Hepatitis C Virus (HCV) Genotype 2 (GT2) infected participants.

Linked Publications (3)

  • Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection.
    Hepatology (Baltimore, Md.) · 2018 · 113 citations · Open access · Likely link
  • Integrated Resistance Analysis of CERTAIN-1 and CERTAIN-2 Studies in Hepatitis C Virus-Infected Patients Receiving Glecaprevir and Pibrentasvir in Japan.
    Antimicrobial agents and chemotherapy · 2018 · 49 citations · Open access · Likely link
  • Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection.
    Journal of gastroenterology · 2019 · 19 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Non-inferiority of Arm A to Arm B
97.8; 93.5
SECONDARY
Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
97.8
SECONDARY
Percentage of Participants With With On-treatment Virologic Failure
0; 0
SECONDARY
Percentage of Participants With Post-Treatment Relapse
0; 4.4

Eligibility Criteria

Inclusion Criteria

  • Females were postmenopausal for at least 2 years prior to screening; 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 indicating HCV GT-2 infection without co-infection of any other genotype.
  • Participant has positive anti-HCV antibody (Ab) and plasma HCV RNA viral load greater than or equal to 1000 IU/mL at Screening Visit.
  • Chronic HCV infection defined as one of the following:
  • Positive for anti-HCV Ab and/or HCV RNA at least 6 months before Screening; or
  • A liver biopsy consistent with chronic HCV infection.
  • Participant must be HCV treatment-naïve (i.e., patient has not received a single dose of any approved or investigational DAA) and non-cirrhotic. Prior HCV treatment using IFNs with or without ribavirin is acceptable. Previous HCV Interferon (IFN) based treatment must have been completed greater than or equal to 2 months prior to screening.

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.
  • 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) or anti human immunodeficiency virus antibody (HIV Ab).
  • Requirement for and inability to safely discontinue contraindicated medications or supplements at least 2 weeks or 10 half-lives (whichever is longer) prior to the first dose of any study drug.
  • Clinically significant abnormalities, other than HCV-infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to:
  • Uncontrolled diabetes as defined by a glycated hemoglobin (hemoglobin A1C) level > 8.5% at the Screening Visit.
  • Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years, or any history of hepatocellular carcinoma (HCC).
  • Uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection.
  • Any cause of liver disease other than chronic HCV-infection, including but not limited to the following:
  • Hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, autoimmune hepatitis, alcoholic liver disease, or steatohepatitis considered to be the primary cause of the liver disease rather than concomitant/incidental with HCV infection.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02723084) 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.

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