NCT02442284

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

May 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

May 13, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 30, 2017

Completed
Last Updated

October 16, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

May 11, 2015

Results QC Date

July 31, 2017

Last Update Submit

September 14, 2017

Conditions

Chronic Hepatitis CCirrhosisHepatitis C Virus

Keywords

Chronic Hepatitis CInterferon-FreeHepatitis C Genotype 1Hepatitis C VirusHepatitis CCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

    SVR12 was defined as plasma 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. Participants with missing data after backwards imputation were imputed as nonresponders.

    12 weeks after the last actual dose of study drug

Secondary Outcomes (3)

  • Percentage of Participants With Virologic Failure During Treatment

    up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group

  • Percentage of Participants With Post-treatment Relapse

    From the end of treatment through 12 weeks after the last dose of study drug

  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders

    12 weeks after the last actual dose of study drug

Study Arms (1)

3-DAA ± RBV for 12 or 24 weeks

EXPERIMENTAL

3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvirDrug: Ribavirin

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvirDRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Also known as: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333
3-DAA ± RBV for 12 or 24 weeks
RibavirinDRUG

Tablet

3-DAA ± RBV for 12 or 24 weeks

Eligibility Criteria

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

You may qualify if:

  • US military veteran currently receiving healthcare through the Veterans Health Administration
  • Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection
  • Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA \> 1,000 IU/mL at the time of Screening or HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)

You may not qualify if:

  • Women who are pregnant or breastfeeding
  • Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)
  • Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir
  • Any current or past clinical evidence of Child-Pugh B or C classification
  • Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hepatitis C, ChronicFibrosisHepatitis C

Interventions

ombitasvirdasabuvirViekira PakparitaprevirRibavirin

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

  • AbbVie Inc.

    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

May 11, 2015

First Posted

May 13, 2015

Study Start

May 13, 2015

Primary Completion

August 22, 2016

Study Completion

October 31, 2016

Last Updated

October 16, 2017

Results First Posted

August 30, 2017

Record last verified: 2017-09