Clinical Trials

MainTitle

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

This study has been completed
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT02517515

First received: August 5, 2015
Last updated: September 29, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Hepatitis C Virus (HCV)

Drug : ombitasvir/paritaprevir/ritonavir and dasabuvir
Drug : Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 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

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of active study drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
  • Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24) [ Time Frame: 24 weeks after the last actual dose of active study drug ]
    SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Secondary Outcome Measures:
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: up to 12 weeks ]
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of active treatment.
  • Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12 [ Time Frame: From the end of treatment through 12 weeks after the last dose of active study drug ]
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
  • Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24 [ Time Frame: From the end of treatment through 24 weeks after the last dose of active study drug ]
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.

Enrollment: 650
Study Start Date: July 2015
Study Completion Date: June 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Double-blind 3-DAA
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

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Other Name:
  • Viekira Pak
  • paritaprevir also known as ABT-450
  • ombitasvir also known as ABT-267
  • dasabuvir also known as ABT-333

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

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Other Name:
  • Viekira Pak
  • paritaprevir also known as ABT-450
  • ombitasvir also known as ABT-267
  • dasabuvir also known as ABT-333

Drug: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 70 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • 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.


Exclusion Criteria:
  • 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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02517515

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc. AbbVie
More Information

More Information

Additional Information:

Related Info.

Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT02517515   History of Changes  
Other Study ID Numbers: M13-767  
Study First Received: August 5, 2015  
Last Updated: September 29, 2017  

Keywords provided by AbbVie:

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

Additional relevant MeSH terms:
Infection
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Ritonavir

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.