NCT02476617

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

September 5, 2017

Completed
Last Updated

October 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

June 17, 2015

Results QC Date

August 3, 2017

Last Update Submit

September 5, 2017

Conditions

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

Keywords

Treatment naiveInterferon freeHCVChronic Hepatitis CHepatitis C Genotype 1aHepatitis Cpegylated-interferon (pegIFN)/ribavirin (RBV) experienced

Outcome Measures

Primary Outcomes (1)

  • Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12

    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 (\<LLOQ) 12 weeks after the last dose of study drug. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.

    Week 0 to Post-Treatment Week 12

Study Arms (1)

Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV

EXPERIMENTAL

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/ritonavirDrug: dasabuvirDrug: ribavirin

Interventions

ombitasvir/paritaprevir/ritonavirDRUG

ombitasvir/ABT-450/ritonavir tablets

Also known as: ABT-267/ABT-450/ritonavir
Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV
dasabuvirDRUG

dasabuvir tablets

Also known as: ABT-333
Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV
ribavirinDRUG

ribavirin tablets

Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 36972796DERIVED

  • 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.

    PMID: 34312544DERIVED

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

ombitasvirdasabuvirRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
800-633-9110

Study Officials

  • Emily Dumas, PhD

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 19, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

October 3, 2017

Results First Posted

September 5, 2017

Record last verified: 2017-08