ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

NCT ID: NCT02517528

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-20
• Study Completion Date: 2017-03-16

Brief Summary

This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis.

Conditions

Chronic Hepatitis C Virus (HCV)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABT-450/r/ABT-267 + ABT-333 + Ribavirin

ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks

Group Type: EXPERIMENTAL

ABT-450/r/ABT-267

Intervention Type: DRUG

Tablet

ABT-333

Intervention Type: DRUG

Tablet

ribavirin

Intervention Type: DRUG

Tablet

Interventions

ABT-450/r/ABT-267

Tablet

Intervention Type: DRUG

ABT-333

Tablet

Intervention Type: DRUG

ribavirin

Tablet

Intervention Type: DRUG

Other Intervention Names

ombitasvir/paritaprevir/ritonavir; ombitasvir also known as ABT-267; paritaprevir also known as ABT-450; dasabuvir

Eligibility Criteria

Inclusion Criteria

1. Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.

2. Chronic HCV-infection prior to study enrollment.

3. Screening laboratory result indicating HCV genotype 1b-infection.

4. Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.

5. Per local standard practice, documentation of cirrhosis by one of the following methods:

• Diagnosis on previous liver biopsy or liver biopsy conducted during screening e.g., Metavir Score of > 3 (including 3/4 or 3 - 4), Ishak score of > 4 or,
• FibroScan score ≥ 14.6 kiloPascals (kPa) within 6 months of Screening or during the Screening Period.

Exclusion Criteria

1. HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.

2. Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or hepatitis B virus (HBV) DNA > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-Human Immunodeficiency virus antibody (HIV Ab).

3. Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.

4. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

5. Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.

6. Confirmed presence of hepatocellular carcinoma (HCC) indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result should be confirmed with CT scan or MRI.)

7. Any primary 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 Steatosis and steatohepatitis on a liver biopsy coincident with HCV-related changes would not be considered exclusionary unless the steatohepatitis is considered to be the primary cause of the liver disease.

8. Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

References

Zha J, Ding B, Wang H, Zhao W, Yu C, Alves K, Mobashery N, Luo Y, Menon RM. Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients. Eur J Drug Metab Pharmacokinet. 2019 Feb;44(1):43-52. doi: 10.1007/s13318-018-0492-8.

Reference Type: DERIVED

PMID: 29909549 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

M14-491

Identifier Type: -

Identifier Source: org_study_id