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Clinical Trials

MainTitle

Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults

This study has been completed
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT02476617

First received: June 17, 2015
Last updated: September 5, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.

Condition Intervention Phase
Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1a

Drug : ombitasvir/paritaprevir/ritonavir
Drug : dasabuvir
Drug : ribavirin
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Evaluate Immune Restoration Following Removal of Viral Antigen in Treatment-Naïve and Treatment-Experienced Adults With Genotype (GT) 1a Chronic Hepatitis C Virus (HCV) Infection Administered Ombitasvir/ ABT-450/Ritonavir With Dasabuvir and Ribavirin (RBV) for 12 Weeks

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12 [ Time Frame: Week 0 to Post-Treatment Week 12 ]
    The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (

Enrollment: 25
Study Start Date: June 2015
Study Completion Date: December 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV
Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily [QD]) + dasabuvir (250 mg twice daily [BID]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
Drug: ombitasvir/paritaprevir/ritonavir

ombitasvir/ABT-450/ritonavir tablets

Other Name: ABT-267/ABT-450/ritonavir
Drug: dasabuvir

dasabuvir tablets

Other Name: ABT-333
Drug: ribavirin

ribavirin tablets

Detailed Description:

A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 100 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a infection.
    2. Chronic HCV infection.
    3. Participants must be non-cirrhotic.
    4. Participants must be treatment-naïve or have documentation that they were adherent to prior pegIFN/RBV combination therapy and meet the criteria of prior pegylated-interferon (pegIFN)/ribavirin (RBV) treatment failure.
    5. Participants must meet specific human leukocyte antigen (HLA) allele requirements.


Exclusion Criteria:
    1. Women who are pregnant or breastfeeding.
    2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
    3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
    4. Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than pegIFN or RBV (including previous exposure to paritaprevir, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
    5. History of solid organ transplant.
    6. Screening laboratory analysis that shows abnormal results.

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02476617

Sponsors and Collaborators

AbbVie

Investigators

Study Director: Emily Dumas, PhD AbbVie
More Information

More Information


Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT02476617   History of Changes  
Other Study ID Numbers: M14-243  
Study First Received: June 17, 2015  
Last Updated: September 5, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by AbbVie:

Treatment naive
Interferon free
HCV
Chronic Hepatitis C
Hepatitis C Genotype 1a
Hepatitis C
pegylated-interferon (pegIFN)/ribavirin (RBV) experienced

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Interferons
Ribavirin
Ritonavir

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.