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A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection

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ClinicalTrials.gov Identifier: NCT01672983
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : November 26, 2015
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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Brief Summary:
This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were previous treated with pegylated interferon/ribavirin (pegIFN/RBV).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: ABT-450/ritonavir, ABT-267 Phase 2

Detailed Description:
This multicenter, randomized, open-label, parallel-arm, combination treatment study consisted of a Treatment and Post-treatment Phase, divided into 2 cohorts: 1) chronic HCV GT1b- infected, pegIFN/RBV treatment-exposed Japanese adults; and 2) HCV GT2-infected, pegIFN/RBV treatment-exposed Japanese adults. The Treatment Phase evaluated the antiviral activity, safety, and pharmacokinetics of a range of ABT-450/r and ABT-267 doses for 12 to 24 weeks. The Post-treatment Phase evaluated the evolution and persistence of viral resistance to ABT-267 and ABT-450.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
Study Start Date : July 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
 Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-450 also known as paritaprevir
  • ABT-267 also known as ombitasvir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 2
Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
 Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-450 also known as paritaprevir
  • ABT-267 also known as ombitasvir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 3
Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
 Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-450 also known as paritaprevir
  • ABT-267 also known as ombitasvir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 4
Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
 Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-450 also known as paritaprevir
  • ABT-267 also known as ombitasvir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 5
Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
 Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-450 also known as paritaprevir
  • ABT-267 also known as ombitasvir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 6
Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
 Drug: ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Names:
  • ABT-450 also known as paritaprevir
  • ABT-267 also known as ombitasvir
  • ritonavir also known as Norvir
  • ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24) [ Time Frame: 24 weeks after last dose of study drug ]
    The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.

  2. Number of Participants With Adverse Events (AEs) [ Time Frame: TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups. ]
    An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.


Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) [ Time Frame: 12 weeks after last dose of study drug ]
    The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.

  2. Percentage of Participants With End of Treatment (EOT) Response [ Time Frame: 12 or 24 weeks after first dose of study drug ]
    The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
  • Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA level greater than 10,000 IU/mL at screening) previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
  • Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null responder or partial responder, OR
  • Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null responder, partial responder, or relapser (Null responder: received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable (HCV RNA < lower limit of detection [< LLOD]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up).

Exclusion Criteria:

  • Significant liver disease with any cause other than HCV as the primary cause
  • Positive screen for drugs or alcohol.
  • Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
  • Use of contraindicated medications within 2 weeks of dosing
  • Previous use of any investigational or commercially available anti-Hepatitis C virus agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.
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): NCT01672983


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Layout table for investigator information
Study Director: Takuma Matsuda, MS AbbVie GK.
More Information
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Additional Information:

Publications of Results:

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

Layout table for additonal information
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01672983    
Other Study ID Numbers: M12-536
First Posted: August 27, 2012    Key Record Dates
Results First Posted: November 26, 2015
Last Update Posted: May 30, 2018
Last Verified: October 2015
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Japanese
Hepatitis C
Genotype 2
Genotype 1b
 paritaprevir
ombitasvir
ritonavir
VIEKIRAX Combination Tablets
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Virus Diseases
Hepatitis
Hepatitis, Chronic
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
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