NCT02851069

Brief Summary

This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label. This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

6 active sites

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

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

February 23, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 18, 2019

Completed
Last Updated

September 18, 2019

Status Verified

May 1, 2019

Enrollment Period

1.5 years

First QC Date

July 28, 2016

Results QC Date

August 12, 2019

Last Update Submit

August 12, 2019

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis CParitaprevir/r - Ombitasvir, ± DasabuvirSustained Virological ResponseObservational StudyChronic Hepatitis C genotype 1

Outcome Measures

Primary Outcomes (1)

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

    SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN \[paritaprevir/ritonavir - ombitasvir ± dasabuvir\] or ribavirin \[RBV\]).

    12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)

Secondary Outcomes (9)

  • Percentage of Participants With Virologic Response at End of Treatment (EoT)

    Up to EoT, maximum of 24 weeks

  • Number of Participants Meeting Premature Study Drug Discontinuation

    Up to EoT, maximum of 24 weeks

  • Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria

    During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)

  • Percentage of Participants With Relapse

    12 weeks (i.e. at least 70 days) after the last dose of study drug

  • Percentage of Participants With Relapse at EoT

    12 weeks (i.e. at least 70 days) after the last dose of study drug

  • +4 more secondary outcomes

Other Outcomes (8)

  • EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT

    EoT (up to 24 weeks)

  • EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT

    12 weeks post EoT (up to 24 weeks)

  • EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT

    24 weeks post EoT (up to 24 weeks)

  • +5 more other outcomes

Study Arms (1)

Participants with Hepatitis C Virus Genotype 1 (HCV + GT1)

ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] with or without dasabuvir \[250 mg twice daily\]), and with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks in HCV + GT1 participants.

Eligibility Criteria

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

Participants with chronic hepatitis C (CHC), genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.

You may qualify if:

  • Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) ± 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).
  • Participant 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

Study Sites (6)

Fundacion Cardioinfantil

Bogotá, Colombia

Location

Cic Cali

Cali, 760001, Colombia

Location

Centro Medico lmbanaco de Cali I

Cali, Colombia

Location

Pharos Centro de Estudios Clin

Cartagena, 130013, Colombia

Location

IPS Medicos Internistas Del Ca I

Manizales, 170004, Colombia

Location

Fundacion Hospitalaria San Vin

Medellín, 050010, Colombia

Location

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

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

  • AbbVie Inc.

    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

July 28, 2016

First Posted

August 1, 2016

Study Start

February 23, 2017

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

September 18, 2019

Results First Posted

September 18, 2019

Record last verified: 2019-05

Locations

CO(6)