NCT01704755

Brief Summary

The purpose of this study is to evaluate the safety and efficacy 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) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
381

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 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

September 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
8 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

1.3 years

First QC Date

September 28, 2012

Results QC Date

December 23, 2014

Last Update Submit

July 8, 2021

Conditions

Chronic Hepatitis C InfectionCompensated Cirrhosis

Keywords

CirrhosisHepatitis CChild Pugh ACompensated CirrhosisHepatitis C Genotype 1CirrhoticChronic Hepatitis CHepatitis C VirusombitasvirparitaprevirdasabuvirInterferon-FreeViekira Pak

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment

    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.

    12 weeks after the last actual dose of study drug

Secondary Outcomes (3)

  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm

    12 weeks after the last actual dose of study drug

  • Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period

    Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

  • Percentage of Participants With Virologic Relapse After Treatment

    within 12 weeks after the last dose of study drug

Study Arms (2)

ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks

EXPERIMENTAL

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks

Drug: ABT-450/r/ABT-267, ABT-333Drug: Ribavirin (RBV)

ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks

EXPERIMENTAL

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks

Drug: ABT-450/r/ABT-267, ABT-333Drug: Ribavirin (RBV)

Interventions

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

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

Also known as: Viekira Pak; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ABT-333 also known as dasabuvir
ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeksABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks
Ribavirin (RBV)DRUG

Capsule

ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeksABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks

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
  • Male or female between 18 and 70 years, inclusive, at time of Screening.
  • Chronic HCV-infection prior to study enrollment.
  • Screening laboratory result indicating HCV genotype 1-infection.
  • Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
  • Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

You may not qualify if:

  • Significant liver disease with any cause other than HCV as the primary cause
  • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
  • Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
  • Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
  • A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X, Lovell SS, Da Silva-Tillmann B, Collins CA, Campbell AL, Podsadecki T, Bernstein B. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014 May 22;370(21):1973-82. doi: 10.1056/NEJMoa1402869. Epub 2014 Apr 11.

    PMID: 24725237BACKGROUND

  • 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

  • Forns X, Poordad F, Pedrosa M, Berenguer M, Wedemeyer H, Ferenci P, Shiffman ML, Fried MW, Lovell S, Trinh R, Lopez-Talavera JC, Everson G. Ombitasvir/paritaprevir/r, dasabuvir and ribavirin for cirrhotic HCV patients with thrombocytopaenia and hypoalbuminaemia. Liver Int. 2015 Nov;35(11):2358-62. doi: 10.1111/liv.12931. Epub 2015 Sep 6.

    PMID: 26248955DERIVED

Related Links

MeSH Terms

Conditions

FibrosisHepatitis CHepatitis C, Chronic

Interventions

dasabuvirViekira PakparitaprevirombitasvirRibavirin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Global Medical Information
Organization
AbbVie (prior sponsor, Abbott)
800 633-9110

Study Officials

  • Roger Trinh, 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

September 28, 2012

First Posted

October 11, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

September 1, 2014

Last Updated

July 12, 2021

Results First Posted

January 6, 2015

Record last verified: 2021-07