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Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis

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

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.

Condition or disease Intervention/treatment
Vasculitis Cryoglobulinemia Hepatitis C Drug: new antiviral therapy

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis
Study Start Date : November 2013
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Number of participants with Immunological complete response [ Time Frame: At week 36 ]
    Immunological complete response is defined by negativation of cryoglobulin at week 36.

  3. rate of side effects [ Time Frame: up to week 24 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856243


Contacts
Contact: David Saadoun, MD PHD 142178009 ext +33 david.saadoun@aphp.fr

Locations
France
hopital La pitié Salpétrière Recruiting
Paris, France, 75013
Contact: david saadoun, MD phd    142178009 ext +33    david.saadoun@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02856243     History of Changes
Other Study ID Numbers: VASCUVALDIC 2 study
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Vasculitis
Cryoglobulinemia
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Antiviral Agents
Anti-Infective Agents