A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)
An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
1 other identifier
interventional
11
1 country
4
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2010
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 13, 2010
CompletedFirst Posted
Study publicly available on registry
October 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
January 8, 2015
CompletedJanuary 8, 2015
December 1, 2014
7 months
October 13, 2010
December 29, 2014
December 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).
Week 4 through Week 12
Secondary Outcomes (6)
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
Week 2
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4
Week 4
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Post-treatment Day 1 to Post-treatment Week 12
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
Post-treatment Day 1 to Post-treatment Week 24
Time to Failure to Suppress or Rebound During Treatment
Day 1 through Week 12
- +1 more secondary outcomes
Study Arms (1)
ABT-450/r and ABT-072, plus ribavirin (RBV)
EXPERIMENTALABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C.
- Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
- Treatment naïve male or female between the ages of 18 and 65.
- Females must be postmenopausal for at least 2 years or surgically sterile.
- Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection.
- Body mass index 18 to \< 35 kg/m\^2 .
You may not qualify if:
- Significant sensitivity to any drug.
- Use of herbal supplements within 2 weeks prior to study drug dosing.
- Positive screen for certain drugs or alcohol.
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody.
- Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing.
- Prior treatment with any investigational or commercially available anti-hepatitis C virus agents.
- Abnormal laboratory tests.
- Cirrhosis or extensive bridging fibrosis.
- History of cardiac disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Site Reference ID/Investigator# 41128
Los Angeles, California, 90048, United States
Site Reference ID/Investigator# 42262
Chicago, Illinois, 60637, United States
Site Reference ID/Investigator# 41127
San Antonio, Texas, 78215, United States
Site Reference ID/Investigator# 43182
Seattle, Washington, 98101, United States
Related Publications (1)
Lawitz E, Poordad F, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1. J Hepatol. 2013 Jul;59(1):18-23. doi: 10.1016/j.jhep.2013.02.009. Epub 2013 Feb 22.
PMID: 23439262DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
Daniel Cohen, MD
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2010
First Posted
October 15, 2010
Study Start
October 1, 2010
Primary Completion
May 1, 2011
Study Completion
April 1, 2012
Last Updated
January 8, 2015
Results First Posted
January 8, 2015
Record last verified: 2014-12