A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 Infection (Endurance-1)

• Register: EUCTR
• Last refreshed on: 20 February 2017
• Main ID: EUCTR2015-002087-17-ES
• Date of registration: 05/10/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 Infection (Endurance-1)
• Scientific title: A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)
• Date of first enrolment: 18/01/2016
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002087-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Canada, Chile, Germany, Hungary, Israel, Korea, Republic of, Lithuania, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: Abbvie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: Abbvie Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female at least 18 years of age at time of screening.
2. Screening laboratory result indicating HCV GT1 infection.
3. Chronic HCV infection.
4. Subject must be HCV DAA treatment-naïve
5. Subjects must be non-cirrhotic.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 570
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
1. History of severe, life-threatening or other significant sensitivity to any component of the study drug.
2. 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.
3. 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.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Chronic HCV Genotype 1 Infection
MedDRA version: 18.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Name: ABT-493/ABT-530
Product Code: ABT-493/ABT-530
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ABT-493
Current Sponsor code: ABT-493
Other descriptive name: ABT-493
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: ABT-530
Current Sponsor code: ABT-530
Other descriptive name: ABT-530
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Main Objective: To show the non-inferiority in SVR12 rates (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [HCV RNA < LLOQ 12 weeks following therapy]) after 12 weeks of treatment with the combination regimen ABT-493/ABT-530 to the historical SVR rate established by current approved standard of care regimens for GT1 (ombitasvir/ paritaprevir/ritonavir + dasabuvir ± RBV or SOF/LDV for 12 weeks)

Secondary Objective: To show the non-inferiority in SVR12 rates of the ABT-493/ABT-530 regimen for 8 weeks versus 12 weeks of treatment.

Primary end point(s): The percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) in each arm.

Timepoint(s) of evaluation of this end point: 12 weeks following the last dose of study drug

Secondary Outcome(s)

Secondary end point(s): ? The percentage of subjects with on-treatment virologic failure;
? The percentage of subjects with post-treatment relapse.

Timepoint(s) of evaluation of this end point: ? the percentage of subjects with on-treatment virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, or HCV RNA ? LLOQ at the end of treatment with at least 6 weeks of treatment), and
? the percentage of subjects with post-treatment relapse (defined as confirmed HCV RNA ? LLOQ between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment with HCV RNA < LLOQ at the end of treatment; with further breakdown by relapse versus reinfection based on HCV population sequence).

Secondary ID(s)

2015-002087-17-HU

M13-590

Source(s) of Monetary Support

AbbVie Inc.