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

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



Sponsors


Source

Hospices Civils de Lyon

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

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.

Overall Status

Completed

Start Date

2017-03-01

Completion Date

2017-11-01

Primary Completion Date

2017-11-01

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Cryoglobulin level at the end of therapy
End of treatment (12 or 24 weeks)

Number Of Groups

1

Enrollment

47

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

HCV patients with mixed cryoglobulinemia

Other Name

Treatment with direct-acting antiviral agents


Eligibility

Study Pop

HCV patients with mixed cryoglobulinemia

Sampling Method

Non-Probability Sample

Criteria

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:

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

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

Location

Facility

Hospices Civils de Lyon - Croix-Rousse Hospital
Lyon 69004 France

Location Countries

Country

France


Verification Date

2017-11-01

Lastchanged Date

2017-11-09

Firstreceived Date

2017-11-07

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Intervention Browse

Mesh Term

Antiviral Agents


Arm Group

Arm Group Label

HCV patients with mixed cryoglobulinemia

Description

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


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Retrospective


Study First Submitted

November 7, 2017

Study First Submitted Qc

November 9, 2017

Study First Posted

November 14, 2017

Last Update Submitted

November 9, 2017

Last Update Submitted Qc

November 9, 2017

Last Update Posted

November 14, 2017


ClinicalTrials.gov processed this data on November 14, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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