Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis

Hepatitis C Clinical Trial

Official title:

Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02856243
• Other study ID #: VASCUVALDIC 2 study
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2016
• Last updated: September 28, 2016
• Start date: November 2013

Study information

• Verified date: July 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: David Saadoun, MD PHD
• Phone: 142178009
• Email: david.saadoun[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cryoglobulinemia
• Hepatitis
• Hepatitis A
• Hepatitis C
• Vasculitis

Intervention

Drug:
• new antiviral therapy

Locations

Country	Name	City	State
France	hopital La pitié Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants with sustained virological response	A sustained virological response is defined by the absence of detectable serum HCV RNA twelve weeks after the end of antiviral therapy	At week 36	No
Secondary	Number of participants with Immunological complete response	Immunological complete response is defined by negativation of cryoglobulin at week 36.	At week 36	No
Secondary	rate of side effects		up to week 24	Yes