NCT02581163

Brief Summary

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Belgium in a clinical practice patient population.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

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 7, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 6, 2019

Completed
Last Updated

May 6, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

October 19, 2015

Results QC Date

February 6, 2019

Last Update Submit

February 6, 2019

Conditions

Chronic Hepatitis C, Genotype 1 or 4

Keywords

EffectivenessInfluence of adherencePatient reported outcomesOmbitasvir/paritaprevir/ritonavir ± dasabuvirChronic Hepatitis C genotype 1Chronic Hepatitis C genotype 4

Outcome Measures

Primary Outcomes (1)

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

    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria: * evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN * an HCV RNA value ≥50 IU/mL at the last measurement post-baseline * HCV RNA \<50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure

    12 weeks after the last actual dose of study drug

Secondary Outcomes (7)

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

    Up to 24 weeks

  • Percentage of Participants With Relapse

    Up to 48 weeks after the last actual dose of study drug

  • Percentage of Participants With Viral Breakthrough

    Up to 24 weeks

  • Percentage of Participants With On-treatment Virologic Failure

    12 weeks after the last actual dose of study drug

  • Percentage of Participants Meeting Relapse Criteria

    12 weeks after the last actual dose of study drug

  • +2 more secondary outcomes

Study Arms (1)

Participants with HCV genotype 1 or 4

Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks

Drug: Ombitasvir/paritaprevir/ritonavirDrug: DasabuvirDrug: Ribavirin

Interventions

Ombitasvir/paritaprevir/ritonavirDRUG

Co-formulated tablet

Also known as: Ombitasvir also known as ABT-267, Paritaprevir also known as ABT-450
Participants with HCV genotype 1 or 4
DasabuvirDRUG

Tablet

Also known as: ABT-333
Participants with HCV genotype 1 or 4
RibavirinDRUG

Tablet

Participants with HCV genotype 1 or 4

Eligibility Criteria

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

Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin

You may qualify if:

  • Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, 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 was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
  • Participants must not have participated or intended 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

Interventions

ombitasvirparitaprevirdasabuvirRibavirin

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

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

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
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 20, 2015

Study Start

October 7, 2015

Primary Completion

February 12, 2018

Study Completion

February 12, 2018

Last Updated

May 6, 2019

Results First Posted

May 6, 2019

Record last verified: 2019-01