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

NCT02023099 | Completed Phase 3 Results DMC

• 1 other identifier: M13-004
• Study Type: interventional
• Target: 363
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Hepatitis C Infection

Keywords

Hepatitis C; Genotype 1b; Cirrhotic; Treatment Experienced; Treatment Naive; Japanese; ombitasvir; paritaprevir; ritonavir; VIEKIRAX Combination Tablets

Outcome Measures

Primary Outcomes (1)

• Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment

  The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution.

  12 weeks after the last dose of study drug

Secondary Outcomes (6)

• Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment

  up to 12 weeks

• Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation

  up to 12 weeks

• Percentage of Participants in the Active Treatment Group With Post-treatment Relapse

  within 12 weeks after last dose of study drug

• Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation

  within 12 weeks after last dose of study drug

• Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment

  12 weeks after last dose of study drug

Study Arms (3)

Substudy 1, Arm A: DB 2-DAA

EXPERIMENTAL

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

Drug: ABT-450/r/ABT-267

Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA

PLACEBO COMPARATOR

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

Drug: ABT-450/r/ABT-267; Drug: Placebo

Substudy 2, Arm C: OL 2-DAA

EXPERIMENTAL

OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis

Drug: ABT-450/r/ABT-267

Interventions

ABT-450/r/ABT-267 DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267

Also known as: ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as Norvir, VIEKIRAX Combination Tablets, Qurevo, Technivie, VIEKIRA Combination Tablets

Substudy 1, Arm A: DB 2-DAA; Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA; Substudy 2, Arm C: OL 2-DAA

Placebo DRUG

Tablet

Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Publications (2)

• Kumada H, Chayama K, Rodrigues L Jr, Suzuki F, Ikeda K, Toyoda H, Sato K, Karino Y, Matsuzaki Y, Kioka K, Setze C, Pilot-Matias T, Patwardhan M, Vilchez RA, Burroughs M, Redman R. Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis. Hepatology. 2015 Oct;62(4):1037-46. doi: 10.1002/hep.27972. Epub 2015 Aug 25.

  PMID: 26147154 RESULT

• Gopalakrishnan S, Khatri A, Mensing S, Redman R, Menon R, Zha J. Exposure-Response Relationship for Ombitasvir and Paritaprevir/Ritonavir in Hepatitis C Virus Subgenotype 1b-Infected Japanese Patients in the Phase 3 Randomized GIFT-I Study. Adv Ther. 2016 Apr;33(4):670-83. doi: 10.1007/s12325-016-0320-y. Epub 2016 Mar 21.

  PMID: 27084721 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C

Interventions

ombitasvir; paritaprevir; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Nori Yachi

  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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: June 6, 2018
• Results First Posted: November 26, 2015

Record last verified: 2016-09