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A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection (Quartz II/III)

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: NCT02292719
Recruitment Status : Completed
First Posted : November 17, 2014
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus Infection Drug: OBV/PTV/r Drug: Sofosbuvir Drug: Ribavirin (RBV) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis
Actual Study Start Date : December 19, 2014
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (genotype [GT]3, noncirrhotic)
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE

Drug: Sofosbuvir
Tablet
Other Name: Sovaldi

Experimental: Arm B (GT3, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE

Drug: Sofosbuvir
Tablet
Other Name: Sovaldi

Drug: Ribavirin (RBV)
Tablet

Experimental: Arm C (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE

Drug: Sofosbuvir
Tablet
Other Name: Sovaldi

Drug: Ribavirin (RBV)
Tablet

Experimental: Arm D (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE

Drug: Sofosbuvir
Tablet
Other Name: Sovaldi

Drug: Ribavirin (RBV)
Tablet

Experimental: Arm E (GT3, cirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE

Drug: Sofosbuvir
Tablet
Other Name: Sovaldi

Drug: Ribavirin (RBV)
Tablet

Experimental: Arm F (GT3, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE

Drug: Sofosbuvir
Tablet
Other Name: Sovaldi




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.


Secondary Outcome Measures :
  1. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to Week 12 ]
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.

  2. Percentage of Participants With Post-treatment Relapse [ Time Frame: Up to 12 weeks after the last actual dose of active 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.



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.


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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:

  1. Chronic HCV infection prior to study enrollment.
  2. Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).
  3. Absence OR presence of cirrhosis.
  4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)

Exclusion Criteria:

  1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
  2. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
  3. Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).
  4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
  5. Abnormal lab tests.
  6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant

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): NCT02292719


Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: Mariem Charafeddine, MD AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] July 31, 2014
Statistical Analysis Plan  [PDF] July 12, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02292719    
Other Study ID Numbers: M14-567
2014-003147-35 ( EudraCT Number )
First Posted: November 17, 2014    Key Record Dates
Results First Posted: July 6, 2018
Last Update Posted: July 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by AbbVie:
Hepatitis C Virus
Genotype 2
Chronic Hepatitis C
Genotype 3
Non-cirrhotic
Cirrhotic
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Sofosbuvir
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