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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 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: NCT02243293
Recruitment Status : Completed
First Posted : September 17, 2014
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Hepatitis C Virus Drug: ABT-493 Drug: ABT-530 Drug: ribavirin (RBV) Drug: ABT-493/ABT-530 Phase 2 Phase 3

Detailed Description:
The study consisted of four independent parts with treatment and post-treatment periods of enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1 and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 694 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)
Study Start Date : September 19, 2014
Actual Primary Completion Date : October 25, 2016
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm B
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm C
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Drug: ribavirin (RBV)
Tablet

Experimental: Arm D
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm E
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm F
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Drug: ribavirin (RBV)
Tablet

Experimental: Arm G
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm H
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm I
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm J
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm K
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm L
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm M
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm N
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Drug: ribavirin (RBV)
Tablet

Experimental: Arm O
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm P
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Drug: ribavirin (RBV)
Tablet

Experimental: Arm Q1
ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
Drug: ABT-493/ABT-530
Tablet; ABT-493 co-formulated ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET

Experimental: Arm Q2
ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
Drug: ABT-493/ABT-530
Tablet; ABT-493 co-formulated ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET

Experimental: Arm R1
ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
Drug: ABT-493/ABT-530
Tablet; ABT-493 co-formulated ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET

Experimental: Arm R2
ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
Drug: ABT-493/ABT-530
Tablet; ABT-493 co-formulated ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET

Experimental: Arm S1
ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493/ABT-530
Tablet; ABT-493 co-formulated ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET

Experimental: Arm S2
ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
Drug: ABT-493/ABT-530
Tablet; ABT-493 co-formulated ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.

  2. Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.


Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) [ Time Frame: 4 weeks after the last actual dose of study drug ]
    SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.

  2. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment ]
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

  3. Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
  • Chronic HCV infection.
  • Participant had to be either HCV treatment-naïve or treatment-experienced.
  • Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any drug.
  • Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
  • HCV genotype performed during screening indicating co-infection with more than one HCV genotype.

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): NCT02243293


Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02243293    
Other Study ID Numbers: M14-868
2014-002927-90 ( EudraCT Number )
First Posted: September 17, 2014    Key Record Dates
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017
Last Verified: August 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AbbVie:
Hepatitis C Virus (HCV)
Hepatitis C
Chronic Hepatitis C
interferon free
Hepatitis C Genotype 2
Hepatitis C Genotype 3
Hepatitis C Genotype 4
Hepatitis C Genotype 5
Hepatitis C Genotype 6
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents