A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02068222
First received: February 19, 2014
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.


Condition Intervention Phase
Chronic Hepatitis C
Hepatitis C Virus
Drug: ABT-450/r
Drug: ABT-530
Drug: Ribavirin (RBV)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • The percentage of subjects who achieve 12-week sustained virologic response (SVR12) in each treatment arm [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification


Secondary Outcome Measures:
  • The percentage of subjects who achieve 24-week sustained virologic response (SVR24) in each treatment arm [ Time Frame: 24 weeks after last dose of study drug ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification

  • The percentage of subjects with virologic failure during treatment [ Time Frame: Up to Treatment Week 12 ] [ Designated as safety issue: No ]
    Percentage of subjects with quantifiable hepatitis C virus ribonucleic acid throughout the entire treatment period, confirmed quantifiable hepatitis C virus ribonucleic acid after previously having unquantifiable hepatitis C virus ribonucleic acid, or a confirmed increase of at least one log10 in hepatitis C virus ribonucleic acid during treatment

  • The percentage of subjects with Post-Treatment relapse [ Time Frame: Within 12 weeks after the last dose of study drug ] [ Designated as safety issue: No ]
    Percentage of subjects with confirmed quantifiable hepatitis C virus ribonucleic acid among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment


Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
ABT-450/r and ABT-530 co-administered with ribavirin (RBV) for 12 weeks
Drug: ABT-450/r
Tablet
Drug: ABT-530
Tablet
Drug: Ribavirin (RBV)
Tablet
Experimental: Arm 2
ABT-450/r and ABT-530 co-administered for 12 weeks
Drug: ABT-450/r
Tablet
Drug: ABT-530
Tablet

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2.
  • Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.
  • Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
  • Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any drug.
  • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
  • Prior therapy for the treatment of HCV.
  • Any current or past clinical evidence of cirrhosis.
  • Any cause of liver disease other than chronic HCV-infection.
  • HCV genotype co-infection with any other HCV genotype.
  • Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
  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: NCT02068222

Contacts
Contact: Charles E Meyer, BS (847) 938-6564 charles.e.meyer@abbvie.com
Contact: Traci Baker, MS (847) 936-6555 traci.baker@abbvie.com

Locations
United States, Alabama
Site Reference ID/Investigator# 124035 Recruiting
Dothan, Alabama, United States, 36305
Principal Investigator: Site Reference ID/Investigator# 124035         
United States, Texas
Site Reference ID/Investigator# 124037 Recruiting
San Antonio, Texas, United States, 78215
Principal Investigator: Site Reference ID/Investigator# 124037         
United States, Washington
Site Reference ID/Investigator# 124036 Not yet recruiting
Seattle, Washington, United States, 98104
Principal Investigator: Site Reference ID/Investigator# 124036         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Arman Asatryan, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02068222     History of Changes
Other Study ID Numbers: M14-213
Study First Received: February 19, 2014
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Chronic Hepatitis C
Hepatitis C virus
Interferon Free
Hepatitis C Genotype 3
Hepatitis C
HCV

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

ClinicalTrials.gov processed this record on July 20, 2014