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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Cryoglobulinemia, Familial Mixed Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Mixed Cryoglobulinemia Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon - Croix-Rousse Hospital

Lyon, 69004, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAA treatment

Drug

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

Other names: Treatment with direct-acting antiviral agents

Primary outcomes

Cryoglobulin level at the end of therapy

Time frame: End of treatment (12 or 24 weeks)

The primary outcome was the cryoglobulin level at the end of direct-acting antiviral treatment (week 12 or 24 according to treatment duration)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Benefit of Direct-acting Antiviral Therapy in Hepatitis C Virus (HCV) Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Nov 14, 2017
Registry last updated: Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed