Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection (GIFT-II)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus

Treatments: Drug: Ribavirin; Drug: ABT-450/r/ABT-267

Study type: Interventional

Funder types: Industry

Identifiers

NCT02023112

M14-153

Details and patient eligibility

About

This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.

Enrollment: 171 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 genotype 2 infection
• Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at Screening
• Voluntarily sign an informed consent

Exclusion criteria

• Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any HCV genotype other than genotype 2
• 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: None (Open label)

---

171 participants in 2 patient groups

ABT-450/r/ABT-267 plus RBV for 12 weeks

Experimental group

Description:

ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks

Treatment:

Drug: Ribavirin

Drug: ABT-450/r/ABT-267

ABT-450/r/ABT-267 plus RBV for 16 weeks

Experimental group

Description:

ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks

Treatment:

Drug: Ribavirin

Drug: ABT-450/r/ABT-267