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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342261
• Other study ID #: CRC_GHN_2017_002
• Status: Completed
• Phase: N/A
• First received: November 7, 2017
• Last updated: November 9, 2017
• Start date: March 1, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: November 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Cryoglobulinemia
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Mixed Cryoglobulinemia

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Croix-Rousse Hospital	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cryoglobulin level at the end of therapy	The primary outcome was the cryoglobulin level at the end of direct-acting antiviral treatment (week 12 or 24 according to treatment duration)	End of treatment (12 or 24 weeks)