An Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Treatment-Naïve and Treatment-Experienced Asian Adults With GT1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

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

Sponsors

Lead sponsor: AbbVie

Source AbbVie
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.

Overall Status Completed
Start Date July 20, 2015
Completion Date March 16, 2017
Primary Completion Date September 29, 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) 12 weeks after last dose of study drug
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) 24 weeks after last dose of study drug
Secondary Outcome
Measure Time Frame
Percentage of Participants With On Treatment Virologic Failure Within 12 weeks after first dose of study drug
Percentage of Participants With Virologic Relapse Within 12 weeks after the last dose of study drug
Percentage of Participants With Virologic Relapse by Post-Treatment Week 24 Within 24 weeks after the last dose of study drug
Enrollment 104
Condition
Intervention

Intervention type: Drug

Intervention name: ABT-450/r/ABT-267

Description: Tablet

Arm group label: ABT-450/r/ABT-267 + ABT-333 + Ribavirin

Intervention type: Drug

Intervention name: ABT-333

Description: Tablet

Arm group label: ABT-450/r/ABT-267 + ABT-333 + Ribavirin

Other name: dasabuvir

Intervention type: Drug

Intervention name: ribavirin

Description: Tablet

Arm group label: ABT-450/r/ABT-267 + ABT-333 + Ribavirin

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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
AbbVie Inc. Study Director AbbVie
Verification Date

January 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: ABT-450/r/ABT-267 + ABT-333 + Ribavirin

Arm group type: Experimental

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

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov