Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis

NCT ID: NCT02856243

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30

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 and/or refractory HCV-MC patient's population.

Conditions

Vasculitis; Cryoglobulinemia; Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

new antiviral therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• at least 18 years of age or older
• present an active HCV vasculitis defined by a clinically active vasculitis with skin, joint, renal, peripheral nerve, central neurological, digestive, pulmonary and/or cardiac involvement (no histological evidence needed if patient had purpura)
• chronic active HCV infection (positive HCV RNA)
• informed consent

Exclusion Criteria

• non-active cryoglobulinaemia vasculitis
• HIV
• active hepatitis B virus (HBV) infection
• current decompensated cirrhosis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

hopital La pitié Salpétrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David Saadoun, MD PHD

Role: CONTACT

david.saadoun@aphp.fr

142178009 ext. +33

Facility Contacts

david saadoun, MD phd

Role: primary

david.saadoun@aphp.fr

142178009 ext. +33

Other Identifiers

VASCUVALDIC 2 study

Identifier Type: -

Identifier Source: org_study_id