Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis

• ClinicalTrials.gov Identifier: NCT02856243
• Recruitment Status: Unknown
• First Posted: August 4, 2016
• Last Update Posted: September 29, 2016
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: July 19, 2016
• First Posted Date: August 4, 2016
• Last Update Posted Date: September 29, 2016
• Study Start Date: November 2013
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 31, 2016)

Number of participants with complete clinical response of cryoglobulinaemia vasculitis [ Time Frame: At week 24 ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 31, 2016)

• Number of participants with sustained virological response [ Time Frame: At week 36 ]
  A sustained virological response is defined by the absence of detectable serum HCV RNA twelve weeks after the end of antiviral therapy
• Number of participants with Immunological complete response [ Time Frame: At week 36 ]
  Immunological complete response is defined by negativation of cryoglobulin at week 36.
• rate of side effects [ Time Frame: up to week 24 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis
• Official Title: Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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).

Condition

• Vasculitis
• Cryoglobulinemia
• Hepatitis C

• Intervention: Drug: new antiviral therapy
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 31, 2016): 120
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02856243
• Other Study ID Numbers: VASCUVALDIC 2 study
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: July 2016