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

NCT ID: NCT02476617

Last Updated: 2017-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 1a

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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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)

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

ombitasvir/ABT-450/ritonavir tablets

dasabuvir

Intervention Type DRUG

dasabuvir tablets

ribavirin

Intervention Type DRUG

ribavirin tablets

Interventions

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ombitasvir/paritaprevir/ritonavir

ombitasvir/ABT-450/ritonavir tablets

Intervention Type DRUG

dasabuvir

dasabuvir tablets

Intervention Type DRUG

ribavirin

ribavirin tablets

Intervention Type DRUG

Other Intervention Names

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ABT-267/ABT-450/ritonavir ABT-333

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 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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Emily Dumas, PhD

Role: STUDY_DIRECTOR

AbbVie

References

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Cui A, Li B, Wallace MS, Gonye ALK, Oetheimer C, Patel H, Tonnerre P, Holmes JA, Lieb D, Yao BS, Ma A, Roberts K, Damasio M, Chen JH, Piou D, Carlton-Smith C, Brown J, Mylvaganam R, Hon Fung JM, Sade-Feldman M, Aneja J, Gustafson J, Epstein ET, Salloum S, Brisac C, Thabet A, Kim AY, Lauer GM, Hacohen N, Chung RT, Alatrakchi N. Single-cell atlas of the liver myeloid compartment before and after cure of chronic viral hepatitis. J Hepatol. 2024 Feb;80(2):251-267. doi: 10.1016/j.jhep.2023.02.040. Epub 2023 Mar 25.

Reference Type DERIVED
PMID: 36972796 (View on PubMed)

Tonnerre P, Wolski D, Subudhi S, Aljabban J, Hoogeveen RC, Damasio M, Drescher HK, Bartsch LM, Tully DC, Sen DR, Bean DJ, Brown J, Torres-Cornejo A, Robidoux M, Kvistad D, Alatrakchi N, Cui A, Lieb D, Cheney JA, Gustafson J, Lewis-Ximenez LL, Massenet-Regad L, Eisenhaure T, Aneja J, Haining WN, Chung RT, Hacohen N, Allen TM, Kim AY, Lauer GM. Differentiation of exhausted CD8+ T cells after termination of chronic antigen stimulation stops short of achieving functional T cell memory. Nat Immunol. 2021 Aug;22(8):1030-1041. doi: 10.1038/s41590-021-00982-6. Epub 2021 Jul 26.

Reference Type DERIVED
PMID: 34312544 (View on PubMed)

Other Identifiers

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M14-243

Identifier Type: -

Identifier Source: org_study_id