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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 Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection

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ClinicalTrials.gov Identifier: NCT02243280
Recruitment Status : Completed
First Posted : September 17, 2014
Results First Posted : April 6, 2017
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1 (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially planned in the protocol, it was not administered in any of the study arms.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Hepatitis C Virus HCV Drug: ABT-493 Drug: ABT-530 Phase 2

Detailed Description:
This study consisted of two independent parts: Part 1 was conducted first followed by Part 2. Part 1 enrolled participants who received ABT-493 and ABT-530 for 12 weeks; Part 2 enrolled participants who received ABT-493 and ABT-530 for 8 or 12 weeks. Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks to monitor HCV RNA to evaluate efficacy and the emergence and persistence of viral variants.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)
Study Start Date : August 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected 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) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected 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) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm D
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm E
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm F
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm G
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm H
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm I
ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm J
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir

Experimental: Arm K
ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Drug: ABT-493
Tablet
Other Name: glecaprevir

Drug: ABT-530
Tablet
Other Name: pibrentasvir




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment [ Time Frame: 12 weeks after the last actual dose of study drug ]
    The percentage of participants with sustained virologic response (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 (SVR) 4 Weeks Post-treatment [ Time Frame: 4 weeks after the last actual dose of study drug ]
    The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] 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: Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment ]
    The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ 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 hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ 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.



Information from the National Library of Medicine

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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:

  1. Male or female between 18 and 70 years of age, inclusive, at time of screening
  2. Screening laboratory result indicating hepatitis C virus (HCV) GT1 (Study Parts 1 and 2) or GT4, GT5, or GT6 (Study Part 2) infection
  3. Chronic HCV infection defined as one of the following:

    • Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening, and positive for HCV RNA and anti-HCV Ab at the time of screening or
    • Positive for anti-HCV Ab and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of chronic HCV infection)
  4. Participant had to meet one of the following criteria:

    • Treatment-naïve: participant had never received treatment for HCV infection
    • Treatment-experienced: pegylated-interferon alpha-2a or alpha-2b and ribavirin (PR)-null responder (for Study Part 1) or PR-experienced (on-treatment failure or prior relapse) (for Study Part 2)
  5. Documented absence of cirrhosis (in Study Part 1 and in corresponding arms of Study Part 2), or compensated cirrhosis (in corresponding arms of Study Part 2, GT1 only), per local standard

Exclusion Criteria:

  1. History of severe, life-threatening or other significant sensitivity to any drug
  2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study
  3. 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
  4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
  5. Hepatitis C virus (HCV) genotype performed during screening indicating co-infection with more than one HCV genotype
  6. Any cause of liver disease other than chronic HCV infection
  7. Participants with plasma HCV RNA load ≤ 10,000 international units (IU)/mL or unquantifiable or undetectable HCV RNA at screening
  8. Previous use of an HCV direct-acting antiviral agent (DAA)
  9. Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493, ABT-530, or RBV (RBV for cirrhotic subjects only)
  10. For participants in Study Part 2 who were enrolling with compensated cirrhosis: past clinical evidence of Child-Pugh B or C Classification (score of > 6) or clinical history of liver decompensation, including ascites (noted on physical exam), bleeding varices, use of beta-blockers for portal hypertension or ascites, or hepatic encephalopathy

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): NCT02243280


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Armen Asatryan, MD AbbVie
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02243280    
Other Study ID Numbers: M14-867
2014-002925-36 ( EudraCT Number )
First Posted: September 17, 2014    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AbbVie:
HCV GT4
Hepatitis C virus
HCV GT1
HCV
Compensated Cirrhosis
HCV GT6
Hepatitis C Genotype 4 (GT 4)
Hepatitis C Genotype 1 (GT1)
RBV
Cirrhotic
Hepatitis C
Interferon (IFN) Free
IFN free
HCV GT5
Chronic Hepatitis C
Ribavirin
Child Pugh A
Hepatitis C Genotype 5 (GT 5)
Hepatitis C Genotype 6 (GT 6)
ABT-493
ABT-530
glecaprevir
pibrentasvir
Additional relevant MeSH terms:
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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