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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT02640482
• Date of registration: 18/12/2015
• Prospective Registration: No
• Primary sponsor: AbbVie
• Public title: A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection ENDURANCE-2
• Scientific title: A Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 2 Infection (ENDURANCE-2)
• Date of first enrolment: November 2015
• Target sample size: 304
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02640482
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Belgium, France, Italy, Korea, Republic of, Lithuania, Portugal, Taiwan, United States

Contacts

• Name: AbbVie Inc
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Screening laboratory result indicating hepatitis C virus (HCV) Genotype-2 (GT2)
infection.

- Chronic HCV infection.

- Subject must be HCV treatment-naïve (subject had never received a single dose of any
approved or investigational regimen) or had failed prior interferon (IFN) or
pegylated-interferon (pegIFN) ± ribavirin (RBV) or sofosbuvir (SOF) + RBV ± pegIFN
therapy.

- Subject must be non-cirrhotic.

Exclusion Criteria:

- History of severe, life-threatening or other significant sensitivity to any excipient
of the study drugs.

- Female who is pregnant, planning to become pregnant during the study, or
breastfeeding; or male whose partner is 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).

- HCV genotype performed during screening indicating coinfection with more than 1 HCV
genotype.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C Virus (HCV) Infection

Intervention(s)

Drug: ABT-493/ABT-530

Drug: Placebo for ABT-493/ABT-530

Primary Outcome(s)

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis [Time Frame: 12 weeks after the last actual dose of active study drug]

Secondary Outcome(s)

Percentage of Participants With On-treatment Virologic Failure in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures [Time Frame: Up to Week 12 post baseline]

Percentage of Participants With Post-treatment Relapse in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures [Time Frame: Between End of Treatment (Week 12) and 12 weeks after the last dose of Arm A DB active drug (up to Week 24)]

Percentage of Participants With SVR12 in Arm A DB Active Drug With Prior SOF + RBV ± pegIFN Failure [Time Frame: 12 weeks after the last actual dose of active study drug]

Percentage of Participants With SVR12 in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Superiority Analysis [Time Frame: 12 weeks after the last actual dose of active study drug]

Secondary ID(s)

M15-464

2015-002348-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/09/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02640482