Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
Information provided by (Responsible Party)
First received: June 17, 2015
Last updated: September 5, 2017
Last Verified: August 2017
History of Changes
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.
Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1a
Drug : ombitasvir/paritaprevir/ritonavir
Drug : dasabuvir
Drug : ribavirin
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 (
|Study Start Date:||June 2015|
|Study Completion Date:||December 2016|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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)
Other Name: ABT-267/ABT-450/ritonavir
Other Name: ABT-333
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
|Ages Eligible for Study:||18 Years to 100 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a infection.
- Chronic HCV infection.
- Participants must be non-cirrhotic.
- 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.
- Participants must meet specific human leukocyte antigen (HLA) allele requirements.
- Women who are pregnant or breastfeeding.
- Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
- Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
- 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.
- History of solid organ transplant.
- Screening laboratory analysis that shows abnormal results.
Contacts and LocationsChoosing 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 CollaboratorsAbbVie
|Study Director:||Emily Dumas, PhD||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
Chronic Hepatitis C
Hepatitis C Genotype 1a
pegylated-interferon (pegIFN)/ribavirin (RBV) experienced
Additional relevant MeSH terms:
Hepatitis C, Chronic
ClinicalTrials.gov processed this data on March 21, 2018
This information is provided by ClinicalTrials.gov.