Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02856243
Status:
UNKNOWN
Last Update Posted:
2016-09-29
First Post:
2016-07-19
Brief Title:
Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cryoglobulinemia are responsible for systemic vasculitis and the most frequently targeted organs are the skin joints kidney and peripheral nervous system Cryoglobulinemia vasculitides are associated with significant morbidity and mortality and require therapeutic intervention With the discovery of hepatitis C virus HCV as the etiologic agent for most cases of mixed cryoglobulinemia new opportunities and problems for crafting therapy of HCV mixed cryoglobulinemia MC have emerged A new and major concern was the potential adverse effects that immunosuppressive therapy with glucocorticoids and cytotoxic drugs could have on an underlying chronic viral infection Alternatively the discovery of HCV provided the opportunity to control HCV-MC with antiviral therapy based on the belief that the underlying infection was driving immune complex formation and resultant vasculitis Inducing a sustained virologic and clinical response and minimizing the use of immunosuppressive drugs are the main goals in the treatment of patients with HCV-MC vasculitis Aggressive antiviral therapy has been shown to induce a complete remission of HCV-MC in up to 70 of patients New antiviral combination Interferon IFN-free regimens have recently proved very high virological response rate and with a very good safety profile and now need to be evaluated in severe andor refractory HCV-MC patients population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None