A Study to evaluate the effect and safety of experimental drugs ABT-493/ABT-530 in adults with Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)

• Register: EUCTR
• Last refreshed on: 8 January 2018
• Main ID: EUCTR2015-005577-20-PL
• Date of registration: 16/05/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study to evaluate the effect and safety of experimental drugs ABT-493/ABT-530 in adults with Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
• Scientific title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotypes 1-6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-infection (EXPEDITION-2)
• Date of first enrolment: 30/06/2016
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005577-20
• 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:
• 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, Belarus, Germany, Poland, Puerto Rico, Russian Federation, 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-, 2-, 3-, 4-, 5-, or 6-infection.
3. Subject has positive anti-HCV Ab and plasma HCV RNA viral load = 1000 IU/mL at Screening Visit.
4. Subjects must be HCV treatment-naïve (i.e., subject has not received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed = 2 months prior to Screening.
5. Subjects naïve to ART must have CD4+ count = 500 cells/mm3 (or CD4+ % = 29%) at Screening; or
Subjects on a stable ART regimen must have the following:
• CD4+ count = 200 cells/mm3 (or CD4+ % = 14%) at Screening; and
• Plasma HIV-1 RNA below LLOQ at Screening and at least once during
the 12 months prior to Screening.

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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
1. 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.
2. Positive test result at Screening for hepatitis B surface antigen (HBsAg).
3. Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
4. Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).
5. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.




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

Health Condition(s) or Problem(s) studied

Hepatitis C Virus Infection Human Immunodeficiency Virus Infection Chronic Hepatitis C Compensated Cirrhosis and Non-cirrhotics

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

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)

Secondary Objective: The secondary objectives are to assess:
? The percentages of subjects with on-treatment HCV virologic failure;
? The percentages of subjects with post-treatment HCV relapse.

Additional objectives are:
? To estimate the pharmacokinetics of ABT-493 and ABT-530.
? To evaluate the percentage of HIV-1/HCV co-infected participants on stable ART who maintain HIV RNA suppression at the end of DAA treatment and at 12 week post DAA treatment.
? To evaluate the emergence of HCV resistance-associated variants among the participants who developed HCV virologic failure.
? To evaluate the emergence of HIV drug resistance-associated variants among the participants who developed HIV virologic failure.

Main Objective: The primary objectives of this study are to are to compare the SVR12 rates (12-week sustained virologic response, SVR12 [HCV RNA < LLOQ 12 weeks following therapy]) of 8 or 12 weeks of treatment with ABT-493/ABT-530 combination in HCV genotype 1 – 6 infected subjects with HIV-1 co-infection to a pre-defined threshold, based on the historical SVR12 rate of the current standard of care (i.e., sofosbuvir/ledipasvir for 12 weeks or grazoprevir/elbasvir for 12 weeks) and to assess the safety of treatment with the combination regimen ABT-493/ABT-530 for 8 or 12 weeks in HCV genotype 1 – 6 infected subjects with HIV-1 co-infection.

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

Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) in the ITT population

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Treatment Day 1 to end of treatment and end of treatment to 12 weeks after the last dose of study drug.

Secondary end point(s): The secondary efficacy endpoints are:
? The percentage of subjects with on-treatment HCV virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA = 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA = LLOQ at the end of treatment with at least 6 weeks of treatment),
? The percentage of subjects with post-treatment HCV 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 as planned with HCV RNA < LLOQ at the end of treatment)

Secondary ID(s)

M14-730

2015-005577-20-GB

Source(s) of Monetary Support

AbbVie Inc.