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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02068222
Recruitment Status : Completed
First Posted : February 21, 2014
Results First Posted : February 2, 2017
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis C Hepatitis C Virus Drug: ABT-450/ritonavir (r) Drug: ABT-530 Drug: Ribavirin (RBV) Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068222


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

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02068222    
Other Study ID Numbers: M14-213
First Posted: February 21, 2014    Key Record Dates
Results First Posted: February 2, 2017
Last Update Posted: February 22, 2018
Last Verified: January 2018
Keywords provided by AbbVie:
Hepatitis C
HCV
Interferon Free
 Chronic Hepatitis C
Hepatitis C virus
Hepatitis C Genotype 3
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
 Flaviviridae Infections
Chronic Disease
Disease Attributes
Pathologic Processes
Ritonavir
Ribavirin
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents