A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C Virus
Intervention: ABT-450 (Drug); ABT-267 (Drug); Ritonavir (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AbbVie (prior sponsor, Abbott) Official(s) and/or principal investigator(s):
Shigeki Hashimoto, PhD, Study Director, Affiliation: AbbVie GK
Summary
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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).Percentage of subjects in each treatment arm with treatment-emergent adverse events.
Secondary outcome: 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).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).
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
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# 73695, Tokyo, Japan
Site Reference ID/Investigator# 76327, Tokyo, Japan
Site Reference ID/Investigator# 73717, Yufu, Japan
Additional Information
Starting date: July 2012
Last updated: May 19, 2014
|
