Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis

NCT02856243 | Unknown

• 1 other identifier: VASCUVALDIC 2 study
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with complete clinical response of cryoglobulinaemia vasculitis

  The complete clinical response is defined by improvement of all the affected organs involved at baseline and the absence of clinical relapse. The skin and articular improvement will be evaluated clinically (i.e. disappearance of purpura and/or ulcers and/or skin necrosis, disappearance of arthralgia and/or arthritis). Renal improvement will be evaluated biologically (i.e. proteinuria \<0.3g/24h, disappearance of hematuria and improvement of Glomerular filtration rate (GFR) \> 20% at week 24 if GFR \< 60 ml/min/1.73 m² at diagnosis). Peripheral neurological improvement will be evaluated clinically (i.e. improvement of pains and paraesthesia by visual analogue scales, improvement of muscular testing in case of motor impairment at baseline) and/or electrophysiologically (i.e. improvement of electromyogram abnormalities at week 24 compared to baseline). The neuropathy total symptom score-6 (NTSS-6) will be applied to evaluate individual neuropathy sensory symptoms.

  At week 24

Secondary Outcomes (3)

• Number of participants with sustained virological response

  At week 36

• Number of participants with Immunological complete response

  At week 36

• rate of side effects

  up to week 24

Interventions

new antiviral therapy DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

To be eligible, the patient must have been at least 18 years of age or older, without any upper age limit, informed and 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), and a chronic active HCV infection (positive HCV RNA).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

hopital La pitié Salpétrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Vasculitis; Cryoglobulinemia; Hepatitis C

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Immunoproliferative Disorders; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

David Saadoun, MD PHD

CONTACT

142178009; david.saadoun@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: August 4, 2016
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-07

Locations

FR (1)