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

NCT02517528 | Completed Phase 3 Results DMC

• 1 other identifier: M14-491
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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)

Keywords

HCV Infection; Compensated Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)

  SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority.

  12 weeks after last dose of study drug

• Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)

  SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China.

  24 weeks after last dose of study drug

Secondary Outcomes (3)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: ribavirin

Interventions

ABT-450/r/ABT-267 DRUG

Tablet

Also known as: ombitasvir/paritaprevir/ritonavir, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450

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

ABT-333 DRUG

Tablet

Also known as: dasabuvir

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

ribavirin DRUG

Tablet

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.
• Chronic HCV-infection prior to study enrollment.
• Screening laboratory result indicating HCV genotype 1b-infection.
• Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.
• 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.

You may not qualify if:

• HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.
• 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).
• 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.
• 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.
• Serum Alpha-Fetoprotein (sAFP) \> 100 ng/mL at Screening.
• 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.)
• 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
• Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• 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.

  PMID: 29909549 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

ombitasvir; paritaprevir; dasabuvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 7, 2015
• Study Start: July 20, 2015
• Primary Completion: September 29, 2016
• Study Completion: March 16, 2017
• Last Updated: October 9, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-01