Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection (GIFT I)
Status and phase
Completed
Phase 3
Conditions
Chronic Hepatitis C Infection
Treatments
Drug: ABT-450/r/ABT-267
Drug: Placebo
Details and patient eligibility
About
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.
Enrollment
363 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Chronic HCV-infection prior to study enrollment
- Screening laboratory result indicating HCV subgenotype 1b infection
- Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening
- Voluntarily sign an informed consent
- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
Exclusion criteria
- Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) or any HCV genotype other than subgenotype 1b
- Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir
- 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; drug-related liver disease; clinically significant laboratory abnormalities; uncontrolled clinically significant disease, disorder or medical illness
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
363 participants in 3 patient groups, including a placebo group
Substudy 1, Arm A: DB 2-DAA
Experimental group
Description:
Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents \[2-DAA\]) once daily (QD) for 12 weeks in participants without cirrhosis
Treatment:
Drug: ABT-450/r/ABT-267
Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA
Placebo Comparator group
Description:
DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
Treatment:
Drug: Placebo
Drug: ABT-450/r/ABT-267
Substudy 2, Arm C: OL 2-DAA
Experimental group
Description:
OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Treatment:
Drug: ABT-450/r/ABT-267
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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