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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01672983
First received: July 27, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

A clinical study to evaluate the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in treatment experienced Japanese adults with chronic Hepatitis C Virus infection.


Condition Intervention Phase
Hepatitis C Virus
Drug: ABT-450
Drug: ABT-267
Drug: Ritonavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Assess the percentage of all dosed subjects in each treatment arm with sustained virologic response 24 weeks post-dosing (hepatitis C ribonucleic acid less than lower limit of quantitation at 24 weeks after the last dose of study drug). [ Time Frame: Post Treatment Week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects in each treatment arm with treatment-emergent adverse events. [ Time Frame: Baseline to end of active treatment (up to 24 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the percentage of all dosed subjects in each treatment arm with a sustained virologic response 12 weeks post-dosing (hepatitis C ribonucleic acid less than lower limit of quantitation 12 weeks after the last dose of study drug). [ Time Frame: Post Treatment Week 12 ] [ Designated as safety issue: No ]
  • Assess the percentage of subjects in each arm with end of treatment response (hepatitis C virus ribonucleic acid less than the lower limit of quantitation). [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose of ABT-450 with ritonavir and ABT-267 for duration 1
Subjects with genotype 1b or genotype 2
Drug: ABT-450
ABT-450 (tablet) dosed with ritonavir (capsule)
Drug: ABT-267
ABT-267 (tablet)
Drug: Ritonavir
Ritonavir (capsule)
Other Name: Norvir
Experimental: High dose of ABT-450 with ritonavir and ABT-267 for duration 1
Subjects with genotype 1b or genotype 2
Drug: ABT-450
ABT-450 (tablet) dosed with ritonavir (capsule)
Drug: ABT-267
ABT-267 (tablet)
Drug: Ritonavir
Ritonavir (capsule)
Other Name: Norvir
Experimental: Low dose of ABT-450 with ritonavir and ABT-267 for duration 2
Subjects with genotype 1b
Drug: ABT-450
ABT-450 (tablet) dosed with ritonavir (capsule)
Drug: ABT-267
ABT-267 (tablet)
Drug: Ritonavir
Ritonavir (capsule)
Other Name: Norvir
Experimental: High dose of ABT-450 with ritonavir and ABT-267 for duration 2
Subjects with genotype 1b
Drug: ABT-450
ABT-450 (tablet) dosed with ritonavir (capsule)
Drug: ABT-267
ABT-267 (tablet)
Drug: Ritonavir
Ritonavir (capsule)
Other Name: Norvir

Detailed Description:

The clinical study is intended to examine the potential impact on safety, pharmacokinetics, antiviral activity, dose ranging and emergence of resistant variants, of two different doses of ABT-450 dosed in combination with ritonavir and ABT-267 for two different treatment periods in Pegylated interferon alpha-2a/Ribavirin treatment experienced, Japanese subjects with hepatitis C virus genotype 1b and genotype 2 infection.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously received Pegylated interferon alpha-2a/Ribavirin.
  • Chronic hepatitis C virus infection.
  • Plasma hepatitis C virus ribonucleic acid level greater than 10,000 International Units/milliliter.
  • Voluntarily sign an informed consent.

Exclusion Criteria:

  • History of severe, life-threatening sensitivity to any drug.
  • Females who are pregnant or plan to become pregnant, or breastfeeding.
  • Recent history of drug or alcohol abuse.
  • Positive test result for hepatitis B surface antigen or anti-Human immunodeficiency virus antibodies.
  • Any current or past clinical evidence of cirrhosis.
  • Previous use of any investigational or commercially available anti-Hepatitis C virus agent other than Pegylated interferon alpha-2a and Ribavirin, including previous exposure to ABT-450 or ABT-267.
  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: NCT01672983

Locations
Japan
Site Reference ID/Investigator# 74393
Chuo, Japan
Site Reference ID/Investigator# 76333
Fukui-shi, Japan
Site Reference ID/Investigator# 73719
Fukuoka, Japan
Site Reference ID/Investigator# 76335
Gifu-shi, Japan
Site Reference ID/Investigator# 73697
Hiroshima-shi, Japan
Site Reference ID/Investigator# 73700
Inashiki-shi, Japan
Site Reference ID/Investigator# 77253
Kanazawa-shi, Japan
Site Reference ID/Investigator# 73696
Kawasaki, Japan
Site Reference ID/Investigator# 73716
Kurume-shi, Japan
Site Reference ID/Investigator# 73701
Maebashi-shi, Japan
Site Reference ID/Investigator# 73714
Matsuyama-shi, Japan
Site Reference ID/Investigator# 75373
Musashino-shi, Japan
Site Reference ID/Investigator# 81633
Ogaki-shi, Japan
Site Reference ID/Investigator# 73698
Sapporo-shi, Japan
Site Reference ID/Investigator# 73718
Takamatsu-shi, Japan
Site Reference ID/Investigator# 73703
Tanabe-shi, Japan
Site Reference ID/Investigator# 76327
Tokyo, Japan
Site Reference ID/Investigator# 73695
Tokyo, Japan
Site Reference ID/Investigator# 73717
Yufu, Japan
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Shigeki Hashimoto, PhD AbbVie GK
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01672983     History of Changes
Other Study ID Numbers: M12-536
Study First Received: July 27, 2012
Last Updated: May 19, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Japanese
Genotype 1b
Hepatitis C
Genotype 2

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014