NCT02669940

Brief Summary

This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

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

January 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 14, 2018

Completed
Last Updated

November 14, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

January 28, 2016

Results QC Date

July 2, 2018

Last Update Submit

October 18, 2018

Conditions

Chronic Hepatitis CGenotype 1

Keywords

OmbitasvirDasabuvirParitaprevir

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)

    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.

    12 weeks after the last actual dose of study drug

Secondary Outcomes (8)

  • Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse

    12 weeks after last actual dose of study drug

  • SVR12 Non-Response: Percentage of Participants With Breakthrough

    12 weeks after the last actual dose of study drug

  • SVR12 Non-Response: Percentage of Participants With Failure to Suppress

    12 weeks after the last actual dose of study drug

  • SVR12 Non-Response: Percentage of Participants With Relapse

    12 weeks after last actual dose of study drug

  • SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure

    12 weeks after last actual dose of study drug

  • +3 more secondary outcomes

Other Outcomes (7)

  • Percentage of Participants Achieving SVR12: Additional Analysis

    12 weeks after the last actual dose of study drug

  • Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis

    12 weeks after last actual dose of study drug

  • SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis

    12 weeks after the last actual dose of study drug

  • +4 more other outcomes

Study Arms (1)

Participants With Chronic Hepatitis C Genotype 1

Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

You may qualify if:

  • Patients are eligible for observation in this cohort if the following applies:
  • Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
  • If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)

You may not qualify if:

  • Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • Andrey Strugovschikov, MD

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 1, 2016

Study Start

April 15, 2016

Primary Completion

July 4, 2017

Study Completion

July 4, 2017

Last Updated

November 14, 2018

Results First Posted

November 14, 2018

Record last verified: 2018-07