NCT03122132

Brief Summary

The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

February 20, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

April 11, 2017

Last Update Submit

May 18, 2018

Conditions

Hepatitis C Infection

Keywords

Hepatitis C InfectionOmbitasvir/Paritaprevir/Ritonavir+dasabuvir

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response 12 weeks post-treatment (SVR12)

    Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12) • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.

    12 weeks after the last dose of study drug

Secondary Outcomes (3)

  • Percentage of patients with virologic failure during treatment

    Up to 12 weeks after last dose of study drug

  • Mild fibrosis and sustained virological response 12 weeks post-treatment

    Up to 12 weeks after last dose of study drug

  • Percentage of participants with low baseline viral load and SVR12 weeks post-treatment

    Baseline and 12 weeks after the last dose of drug

Study Arms (1)

Spanish cohort with HCV treated with DAA

Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks

Drug: ombitasvir/paritaprevir/ritonavir 8 weeksDrug: dasabuvir 8 weeks

Interventions

ombitasvir/paritaprevir/ritonavir 8 weeksDRUG

Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks

Also known as: viekirax
Spanish cohort with HCV treated with DAA
dasabuvir 8 weeksDRUG

Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks

Also known as: exviera
Spanish cohort with HCV treated with DAA

Eligibility Criteria

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

Patients with HCV who are treated in real practice with Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir

You may qualify if:

  • Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
  • Genotype 1b infection
  • Treatment-naïve and non-cirrhotic

You may not qualify if:

  • HCV genotype or subtype other than GT1b.
  • Any current or past clinical evidence of cirrhosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carrion, Jose Antonio, PhD

Barcelona, 08003, Spain

Location

Related Publications (1)

  • Puigvehi M, De Cuenca B, Viu A, Diago M, Turnes J, Gea F, Pascasio JM, Lens S, Cabezas J, Badia E, Olveira A, Morillas RM, Torras X, Montoliu S, Cordero P, Castro JL, Salmeron J, Molina E, Sanchez-Ruano JJ, Moreno J, Anton MD, Moreno JM, De la Vega J, Calleja JL, Carrion JA. Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild-moderate fibrosis: Results from a real-world cohort. Liver Int. 2019 Jan;39(1):90-97. doi: 10.1111/liv.13950. Epub 2018 Nov 12.

    PMID: 30160363DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

ombitasvirparitaprevirRitonavirdasabuvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

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

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 20, 2017

Study Start

February 20, 2017

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

ES(1)