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Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

NCT ID: NCT02609659

Last Updated: 2019-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-28

Study Completion Date

2016-12-28

Brief Summary

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This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).

Detailed Description

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Conditions

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Hepatitis C Virus (HCV)

Keywords

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Chronic Hepatitis C Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3-DAA + RBV 600 mg

3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ribavirin

Intervention Type DRUG

Tablet

Interventions

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ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Intervention Type DRUG

ribavirin

Tablet

Intervention Type DRUG

Other Intervention Names

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Viekira Pak paritaprevir also known as ABT-450 ombitasvir also known as ABT-267 dasabuvir also known as ABT-333

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis C virus (HCV) infection
* Non-cirrhotic subjects
* Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
* HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)

Exclusion Criteria

* Pregnant or breastfeeding women
* Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
* HCV genotype of any subtype other than GT1a or unable to subtype
* Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
* Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

Countries

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United States

References

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Poordad F, Sedghi S, Pockros PJ, Ravendhran N, Reindollar R, Lucey MR, Epstein M, Bank L, Bernstein D, Trinh R, Krishnan P, Polepally AR, Unnebrink K, Martinez M, Nelson DR. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis. J Viral Hepat. 2019 Aug;26(8):1027-1030. doi: 10.1111/jvh.13109. Epub 2019 May 6.

Reference Type RESULT
PMID: 30980576 (View on PubMed)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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M15-582

Identifier Type: -

Identifier Source: org_study_id