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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02068222
First received: February 19, 2014
Last updated: December 9, 2016
Last verified: December 2016
  Purpose
The purpose of this study is to evaluate the safety and antiviral effect 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/ritonavir (r)
Drug: ABT-530
Drug: Ribavirin (RBV)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group 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) [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.


Secondary Outcome Measures:
  • The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24) [ Time Frame: 24 weeks after last dose of study drug ]
    SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.

  • The Percentage of Subjects With Virologic Failure During Treatment [ Time Frame: Up to Treatment Week 12 ]
    Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.

  • The Percentage of Subjects With Post-Treatment Relapse [ Time Frame: Within 12 weeks after the last dose of study drug ]
    Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.


Enrollment: 10
Study Start Date: April 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-450/r and ABT-530 plus RBV
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Drug: ABT-450/ritonavir (r)
Tablet
Other Name: ABT-450 also known as paritaprevir
Drug: ABT-530
Tablet
Other Name: pibrentasvir
Drug: Ribavirin (RBV)
Tablet

Detailed Description:
Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Sponsors and Collaborators
AbbVie
Investigators
Study Director: Armen Asatryan, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02068222     History of Changes
Other Study ID Numbers: M14-213 
Study First Received: February 19, 2014
Results First Received: December 9, 2016
Last Updated: December 9, 2016

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ritonavir
Ribavirin
Antiviral Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimetabolites

ClinicalTrials.gov processed this record on February 23, 2017