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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT03342261

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic Mixed Cryoglobulinemia	Drug: DAA treatment

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

47 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
HCV patients with mixed cryoglobulinemia HCV patients with or without HIV presenting a mixed cryoglobulinemia and treated with direct-acting antiviral agents	Drug: DAA treatment Patients were treated with direct-acting antiviral (DAA) treatment for 12 or 24 weeks Other Names: Treatment with direct-acting antiviral agents

Arm

Intervention/Treatment

HCV patients with mixed cryoglobulinemia

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

Drug: DAA treatment

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

Other Names:

Treatment with direct-acting antiviral agents

Outcome Measures

Primary Outcome Measures

Cryoglobulin level at the end of therapy [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon - Croix-Rousse Hospital	Lyon		France	69004

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Study Chair: Fabien Zoulim, MD, PhD, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03342261

Other Study ID Numbers:

CRC_GHN_2017_002

First Posted:

Nov 14, 2017

Last Update Posted:

Nov 14, 2017

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2017