Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks

NCT ID: NCT03122132

Last Updated: 2018-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-20

Study Completion Date

2018-03-01

Brief Summary

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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).

Detailed Description

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HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. 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).

Conditions

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Hepatitis C Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

ombitasvir/paritaprevir/ritonavir 8 weeks

Intervention Type DRUG

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

dasabuvir 8 weeks

Intervention Type DRUG

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

Interventions

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ombitasvir/paritaprevir/ritonavir 8 weeks

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

Intervention Type DRUG

dasabuvir 8 weeks

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

Intervention Type DRUG

Other Intervention Names

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viekirax exviera

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* HCV genotype or subtype other than GT1b.
* Any current or past clinical evidence of cirrhosis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hepa C

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Carrion, Jose Antonio, PhD

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 30160363 (View on PubMed)

Other Identifiers

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0002

Identifier Type: -

Identifier Source: org_study_id

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