ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

NCT02517515 | Completed Phase 3 Results DMC

• 1 other identifier: M13-767
• Study Type: interventional
• Target: 650
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

Conditions

Hepatitis C Virus (HCV)

Keywords

HCV Infection; Chronic Hepatitis C Virus; Hepatitis C Virus (HCV) Genotype 1b

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

  SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) who achieved SVR12 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.

  12 weeks after the last actual dose of active study drug

• Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)

  SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) who achieved SVR24 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.

  24 weeks after the last actual dose of active study drug

Secondary Outcomes (3)

• Percentage of Participants With On-treatment Virologic Failure

  up to 12 weeks

• Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12

  From the end of treatment through 12 weeks after the last dose of active study drug

• Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24

  From the end of treatment through 24 weeks after the last dose of active study drug

Study Arms (2)

Double-blind 3-DAA

EXPERIMENTAL

Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir

Double-blind Placebo Followed by Open-label 3-DAA

EXPERIMENTAL

Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvir DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Also known as: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333

Double-blind 3-DAA; Double-blind Placebo Followed by Open-label 3-DAA

Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir DRUG

Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Double-blind Placebo Followed by Open-label 3-DAA

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 hepatitis C virus (HCV) infection prior to study enrollment.
• Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
• Per local standard practice, documented absence of cirrhosis.
• Participant has never received antiviral treatment (including interferon \[IFN\]-based therapy \[alpha, beta or pegylated (peg)IFN\] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser
• Participant has plasma HCV RNA level \> 10,000 IU/mL at Screening.

You may not qualify if:

• HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.
• Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) \> Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
• Any current or past clinical evidence of cirrhosis.
• Any primary cause of liver disease other than chronic HCV infection.
• Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
• Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.

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

Related Links

• Related Info.

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

ombitasvir; dasabuvir; Viekira Pak; paritaprevir

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; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 7, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2017
• Last Updated: October 27, 2017
• Results First Posted: October 27, 2017

Record last verified: 2017-09