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)

December 29, 2014 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Site Reference ID/Investigator# 41128
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Site Reference ID/Investigator# 42262
    • Texas
      • San Antonio, Texas, United States, 78215
        • Site Reference ID/Investigator# 41127
    • Washington
      • Seattle, Washington, United States, 98101
        • Site Reference ID/Investigator# 43182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABT-450/r and ABT-072, plus ribavirin (RBV)
ABT-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.
Drug: ABT-450
tablets
Drug: ABT-072
tablets
Drug: Ribavirin
tablets
Drug: Ritonavir
capsules
Other Names:
  • Norvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
Time Frame: Week 2
Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.
Week 2
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4
Time Frame: Week 4
Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).
Week 4
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Time Frame: Post-treatment Day 1 to Post-treatment Week 12
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.
Post-treatment Day 1 to Post-treatment Week 12
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
Time Frame: Post-treatment Day 1 to Post-treatment Week 24
Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.
Post-treatment Day 1 to Post-treatment Week 24
Time to Failure to Suppress or Rebound During Treatment
Time Frame: Day 1 through Week 12
The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA <LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD.
Day 1 through Week 12
Time to Virologic Relapse Through 24 Weeks Post-treatment
Time Frame: Post-treatment Day 1 to Post-treatment Week 24
Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.
Post-treatment Day 1 to Post-treatment Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Daniel Cohen, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (Estimate)

October 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 8, 2015

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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