Benefit of DAA Therapy in HCV Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia

NCT ID: NCT03342261

Last Updated: 2017-11-14

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

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-11-01

Brief Summary

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Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.

Detailed Description

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We focused on HCV patients with or without HIV with MC who had at least one cryoglobulin level assessment before and after DAA therapy and investigated the impact of DAA therapy on cryoglobulin clearance.

Conditions

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Hepatitis C, Chronic Mixed Cryoglobulinemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HCV patients with mixed cryoglobulinemia

HCV patients with or without HIV presenting a mixed cryoglobulinemia and treated with direct-acting antiviral agents

DAA treatment

Intervention Type DRUG

Patients were treated with direct-acting antiviral (DAA) treatment for 12 or 24 weeks

Interventions

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DAA treatment

Patients were treated with direct-acting antiviral (DAA) treatment for 12 or 24 weeks

Intervention Type DRUG

Other Intervention Names

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Treatment with direct-acting antiviral agents

Eligibility Criteria

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Inclusion Criteria

* hepatitis C virus (HCV) infected patients
* symptomatic or asymptomatic mixed cryoglobulinemia
* coinfected or not with HIV
* treated by direct-acting antiviral (DAA) treatment
* at least one cryoglobulin measurement before and after DAA

Exclusion Criteria

\-
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: STUDY_CHAIR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon - Croix-Rousse Hospital

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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CRC_GHN_2017_002

Identifier Type: -

Identifier Source: org_study_id