NCT02582658

Brief Summary

The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 6, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

June 5, 2019

Completed
Last Updated

June 5, 2019

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

October 20, 2015

Results QC Date

January 8, 2018

Last Update Submit

February 28, 2019

Conditions

Chronic Hepatitis C

Keywords

ParitaprevirDasabuvirOmbitasvirChronic Hepatitis CHCV

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 study drug.

    12 Weeks after the last dose of study drug

Secondary Outcomes (4)

  • Percentage of Participants With Virological Response at End of Treatment (EoTR)

    Up to 24 weeks of treatment

  • Percentage of Participants With On-treatment Virologic Failure (Breakthrough)

    Up to approximately 24 weeks

  • Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)

    12 weeks after last dose of study drug

  • Percentage of Participants With Post-treatment Relapse

    Up to 12 weeks after last dose of study drug

Other Outcomes (10)

  • Percentage of Planned Duration of Ribavirin (RBV) Taken

    Up to 24 weeks of treatment

  • Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire

    Day 0 and End of Treatment (EoT)

  • Percentage of Participants With Concomitant Medications

    Day 0 to end of treatment (up to 24 weeks)

  • +7 more other outcomes

Study Arms (1)

Chronic infection of HCV GT1 or GT4

Participants with confirmed chronic hepatitis C genotype (GT) 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) ± Ribavirin (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

Patients with chronic infection of HCV Genotype 1 (GT1) or Genotype 4 (GT4)

You may qualify if:

  • Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label
  • If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
  • Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.

    PMID: 30739368DERIVED

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

  • Alexander P Dorr, PhD

    AbbVie Austria

    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

October 20, 2015

First Posted

October 21, 2015

Study Start

October 6, 2015

Primary Completion

January 12, 2017

Study Completion

January 12, 2017

Last Updated

June 5, 2019

Results First Posted

June 5, 2019

Record last verified: 2018-10