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 is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01672983
First received: July 27, 2012
Last updated: January 8, 2013
Last verified: January 2013
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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 ]
| Estimated Enrollment: | 96 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated 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:
- Male or female between the age of 18 and 75 years, inclusive.
- 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
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, Japan | |
| Site Reference ID/Investigator# 73719 | |
| Fukuoka, Japan | |
| Site Reference ID/Investigator# 76335 | |
| Gifu, Japan | |
| Site Reference ID/Investigator# 73697 | |
| Hiroshima, Japan | |
| Site Reference ID/Investigator# 73700 | |
| Inashiki, Japan | |
| Site Reference ID/Investigator# 77253 | |
| Kanazawa, Japan | |
| Site Reference ID/Investigator# 73696 | |
| Kawasaki, Japan | |
| Site Reference ID/Investigator# 73716 | |
| Kurume, Japan | |
| Site Reference ID/Investigator# 73701 | |
| Maebashi, Japan | |
| Site Reference ID/Investigator# 73714 | |
| Matsuyama, Japan | |
| Site Reference ID/Investigator# 75373 | |
| Musashino, Japan | |
| Site Reference ID/Investigator# 81633 | |
| Ogaki, Japan | |
| Site Reference ID/Investigator# 73698 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 73718 | |
| Takamatsu, Japan | |
| Site Reference ID/Investigator# 73703 | |
| Tanabe, 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: | Moriaki Kubo, RPh | 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: | January 8, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by AbbVie:
|
Genotype 2 Genotype 1b Japanese Hepatitis C |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Virus Diseases Hepatitis C, Chronic 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 May 23, 2013