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A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection

NCT ID: NCT01767116

Last Updated: 2021-07-12

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

419 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

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Detailed Description

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A randomized, double-blind, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naïve, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.

Conditions

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Chronic Hepatitis C Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ABT-450/r/ABT-267 and ABT-333, Plus RBV

ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin

Intervention Type DRUG

Capsule

ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV

ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks

Group Type EXPERIMENTAL

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Placebo for ribavirin

Intervention Type DRUG

Capsule

Interventions

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ABT-450/r/ABT-267, ABT-333

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Intervention Type DRUG

Ribavirin

Capsule

Intervention Type DRUG

Placebo for ribavirin

Capsule

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
* Subject has never received antiviral treatment for hepatitis C infection
* No evidence of liver cirrhosis

Exclusion Criteria

* Significant liver disease with any cause other than HCV as the primary cause
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Positive screen for drugs or alcohol
* Significant sensitivity to any drug
* Use of contraindicated medications within 2 weeks of dosing
* Abnormal laboratory tests
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Cohen, MD

Role: STUDY_DIRECTOR

AbbVie

References

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Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR; PEARL-III Study; PEARL-IV Study. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014 May 22;370(21):1983-92. doi: 10.1056/NEJMoa1402338. Epub 2014 May 4.

Reference Type BACKGROUND
PMID: 24795200 (View on PubMed)

Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.

Reference Type DERIVED
PMID: 29377566 (View on PubMed)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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2012-003687-52

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-961

Identifier Type: -

Identifier Source: org_study_id

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