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Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

NCT ID: NCT03318887

Last Updated: 2017-10-24

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

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-01

Study Completion Date

2015-06-30

Brief Summary

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Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.

Detailed Description

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Conditions

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Hepatitis C

Keywords

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Cirrhosis Direct acting antiviral agents Hepatitis C Pharmacological monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sofosbuvir/daclatasvir

Patients with hepatitis C virus (HCV) infection treated with sofosbuvir/daclatasvir combination therapy with or without ribavirin between February and September 2014

Sofosbuvir/daclatasvir with or without ribavirin

Intervention Type DRUG

Direct-acting antiviral treatment for hepatitis C virus infection

Interventions

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Sofosbuvir/daclatasvir with or without ribavirin

Direct-acting antiviral treatment for hepatitis C virus infection

Intervention Type DRUG

Other Intervention Names

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Combination of sofosbuvir and daclatasvir with or without ribavirin

Eligibility Criteria

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Inclusion Criteria

* Patients with hepatitis C virus infection treated with sofosbuvir/daclatasvir
* Patients with at least one measurement of sofosbuvir or daclatasvir plasma concentration
* Follow-up of at least 3 months after the end of treatment

Exclusion Criteria

* Patients with severe renal failure (estimated glomerular filtration rate (eGFR)\<30ml/min/1.73m2)
* Patients with liver transplantation during therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabien Zoulim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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CRC_GHN_2016_001

Identifier Type: -

Identifier Source: org_study_id