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Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

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ClinicalTrials.gov Identifier: NCT02247401
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : July 27, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

Condition or disease Intervention/treatment Phase
HCV Hepatitis C Infection Genotype 4 Drug: 2 DAA Drug: RBV Phase 3

Detailed Description:
Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Safety and Efficacy of the Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Chronic Hepatitis C Virus Genotype 4 Infection in Egypt
Study Start Date : November 4, 2014
Actual Primary Completion Date : August 1, 2016
Actual Study Completion Date : August 1, 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A
ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
 Drug: 2 DAA
ABT-450/r/ABT-267 tablets

Drug: RBV
Ribavirin tablets
Active Comparator: Arm B
ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
 Drug: 2 DAA
ABT-450/r/ABT-267 tablets

Drug: RBV
Ribavirin tablets
Active Comparator: Arm C
ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
 Drug: 2 DAA
ABT-450/r/ABT-267 tablets

Drug: RBV
Ribavirin tablets


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm [ Time Frame: 12 weeks after last dose ]
    SVR12 was defined as 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. Number of Participants With Adverse Events [ Time Frame: Screening until 30 days after last dose ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.


Secondary Outcome Measures :
  1. Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm [ Time Frame: Up to 12 or 24 weeks after first dose ]
    On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.

  2. Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm [ Time Frame: Up to 12 weeks after first dose ]
    Post-treatment relapse was defined as 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 < LLOQ at the end of treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening)

  • Subjects must meet one of the following:

    • Treatment-naive: Subject has never received antiviral treatment for HCV infection OR
    • Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon [pegIFN]/RBV);
  • Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
  • In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
  • In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
  • HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
  • abnormal laboratory tests
  • self-reports current drinking more than 2 drinks per day
  • current enrollment in another investigational study
  • previous treatment with a direct acting antiviral agent (DAA) containing regimen
  • In substudy 1, evidence of liver cirrhosis
  • In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma
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): NCT02247401


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Sarah Kopecky-Bromberg, PhD AbbVie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02247401     History of Changes
Other Study ID Numbers: M14-250
First Posted: September 25, 2014    Key Record Dates
Results First Posted: July 27, 2017
Last Update Posted: August 28, 2017
Last Verified: July 2017
Keywords provided by AbbVie:
Genotype 4
non-responder
treatment experienced
HCV
naive
relapser
hepatitis infection
 compensated cirrhosis
hepatitis c
Cirrhosis
Egypt
null responder
partial responder
Additional relevant MeSH terms:
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Infection
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
 Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors