- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02856243
Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis
September 28, 2016 updated by: Assistance Publique - Hôpitaux de Paris
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75013
- Recruiting
- Hôpital La Pitié Salpêtrière
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At week 36
|
Number of participants with Immunological complete response
Time Frame: At week 36
|
Immunological complete response is defined by negativation of cryoglobulin at week 36.
|
At week 36
|
rate of side effects
Time Frame: up to week 24
|
up to week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
July 19, 2016
First Submitted That Met QC Criteria
July 31, 2016
First Posted (Estimate)
August 4, 2016
Study Record Updates
Last Update Posted (Estimate)
September 29, 2016
Last Update Submitted That Met QC Criteria
September 28, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Immune System Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Liver Diseases
- Hemorrhagic Disorders
- Flaviviridae Infections
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Vasculitis
- Cryoglobulinemia
- Anti-Infective Agents
- Antiviral Agents
Other Study ID Numbers
- VASCUVALDIC 2 study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vasculitis
-
University Hospital, Strasbourg, FranceRecruiting
-
Xiangya Hospital of Central South UniversityThe Third Xiangya Hospital of Central South University; Hunan Provincial People... and other collaboratorsRecruiting
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)TerminatedANCA-Associated VasculitisUnited Kingdom
-
University Hospital, BrestNot yet recruitingOccupational Diseases | ANCA Associated Vasculitis | Environmental ExposureFrance
-
Chinese SLE Treatment And Research GroupThe First Affiliated Hospital of Anhui Medical University; Shanghai Zhongshan... and other collaboratorsRecruitingANCA Associated Vasculitis | Maintenance TherapyChina
-
University Hospital, BrestRecruiting
-
Nantes University HospitalINSERM UMRS-1064CompletedANCA-associated VasculitisFrance
-
University Hospital Birmingham NHS Foundation TrustMerck Sharp & Dohme LLCRecruitingANCA Associated VasculitisUnited Kingdom
-
Second Affiliated Hospital, School of Medicine,...RecruitingANCA Associated VasculitisChina
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)SuspendedANCA Associated VasculitisUnited States
Clinical Trials on new antiviral therapy
-
Loewenstein HospitalRecruitingTraumatic Brain InjuryIsrael
-
Fisher and Paykel HealthcareWithdrawnObstructive Sleep ApneaUnited States
-
Paolo CassanoNorth Suffolk Mental Health Association; Mclean HospitalCompletedMajor Depressive DisorderUnited States
-
Technical University of MunichRecruitingCastration-resistant Prostate CancerGermany
-
Peking University First HospitalRecruitingGestational Diabetes | Induction of Labor Affected Fetus / NewbornChina
-
Thomas More KempenUnknown
-
Hospital Virgen de la SaludCompletedTracheostomy | Airway Management | Respiratory TherapySpain
-
Thomas More KempenOrtho-MedicoUnknown
-
Acibadem UniversityCompleted
-
GenfitNaturalpha; SGS Aster S.A.S.CompletedCardiovascular Diseases | Metabolic Diseases | Diabetes Mellitus, Type 2 | Type 2 Diabetes | Dyslipidemia | ObeseFrance