NCT01674725

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2012

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

First Submitted

Initial submission to the registry

July 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

January 6, 2015

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

July 27, 2012

Results QC Date

December 23, 2014

Last Update Submit

July 8, 2021

Conditions

Chronic Hepatitis C Infection

Keywords

Hepatitis C virusHepatitis C Genotype 1Hepatitis CInterferon-FreeChronic Hepatitis COmbitasvirRibavirinViekira PAKDasabuvirParitaprevir

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses

    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV.

    12 weeks after last dose of study drug

Secondary Outcomes (4)

  • Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment

    Baseline (Day 1) and Week 12 (End of Treatment)

  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses

    12 weeks after last dose of study drug

  • Percentage of Participants With Virologic Failure During Treatment

    Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

  • Percentage of Participants With Virologic Relapse After Treatment

    Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)

Study Arms (2)

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

EXPERIMENTAL

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

Drug: ABT-450/r/ABT-267, ABT-333Drug: Ribavirin

ABT-450/r/ABT-267 and ABT-333

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: ABT-450 also known as paritaprevir, ABT-267 also known as ombitasvir, ABT-333 also known as dasabuvir, Viekira PAK
ABT-450/r/ABT-267 and ABT-333ABT-450/r/ABT-267 and ABT-333, Plus RBV
RibavirinDRUG

Tablet

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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's hepatitis C virus genotype is subgenotype 1b at Screening without co infection with any other genotype/subgenotype.

You may not qualify if:

  • 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
  • Use of contraindicated medications within 2 weeks of dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, Mullhaupt B, Horsmans Y, Weiland O, Reesink HW, Rodrigues L Jr, Hu YB, Podsadecki T, Bernstein B. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology. 2014 Aug;147(2):359-365.e1. doi: 10.1053/j.gastro.2014.04.045. Epub 2014 May 9.

    PMID: 24818763RESULT

  • 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.

    PMID: 29377566DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis CHepatitis C, Chronic

Interventions

dasabuvirparitaprevirombitasvirViekira PakRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Global Medical Information
Organization
AbbVie
800-633-9110

Study Officials

  • Jeffrey Enejosa, MD

    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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2012

First Posted

August 29, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2014

Study Completion

October 1, 2014

Last Updated

July 12, 2021

Results First Posted

January 6, 2015

Record last verified: 2021-07