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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

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ClinicalTrials.gov Identifier: NCT02517515
Recruitment Status : Completed
First Posted : August 7, 2015
Results First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir Drug: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Names:
  • 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 Names:
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 [<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.

  2. 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 [<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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517515


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02517515    
Other Study ID Numbers: M13-767
First Posted: August 7, 2015    Key Record Dates
Results First Posted: October 27, 2017
Last Update Posted: October 27, 2017
Last Verified: September 2017
Keywords provided by AbbVie:
HCV Infection
Chronic Hepatitis C Virus
Hepatitis C Virus (HCV) Genotype 1b
Additional relevant MeSH terms:
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Infections
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
 Communicable Diseases
Flaviviridae Infections
Ritonavir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors