NCT01833533

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 1a (HCV GT1a) infection without cirrhosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
305

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2013

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

February 27, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
4 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

9 months

First QC Date

February 27, 2013

Results QC Date

December 23, 2014

Last Update Submit

July 8, 2021

Conditions

Chronic Hepatitis C Infection

Keywords

Chronic Hepatitis CHepatitis C VirusHepatitis C Genotype 1aHepatitis CTreatment-NaïveInterferon-FreeParitaprevirOmbitasvirDasabuvirRibavirinViekira PAK

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, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a 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, Plus Placebo RBV

EXPERIMENTAL

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

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

Interventions

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

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

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

Capsule

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

Capsule

ABT-450/r/ABT-267 and ABT-333, Plus Placebo 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 1a-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

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
  • Significant sensitivity to any drug
  • Use of contraindicated medications within 2 weeks of dosing
  • Abnormal laboratory tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 24795200BACKGROUND

  • 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 C, ChronicHepatitis C

Interventions

dasabuvirombitasvirparitaprevirViekira PakRibavirin

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 Information
Organization
AbbVie
800-633-9110

Study Officials

  • Yan Luo, 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

April 17, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

September 1, 2014

Last Updated

July 12, 2021

Results First Posted

January 6, 2015

Record last verified: 2021-07