|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
French National Agency for Research on AIDS and Viral Hepatitis |
|---|---|
| Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00574652 |
Purpose
A systemic Vasculitis is found in 5 to 10% of HCV infected patients with mixed cryoglobulinemia (MC). It mainly involves the skin, peripheral nerve and the kidney and may be life threatening. Twenty to 30% of HCV-MC Vasculitis patients are resistant to conventional therapy (i.e. antiviral therapy and/or immunosuppressors) and still have an active disease. Thus, new therapeutic approaches are necessary in such patients. We recently described a regulatory T cell (Treg) deficiency in HCV-related Vasculitis patients. Immunomodulatory effects of interleukin-2 (IL-2) are well established, notably the preferential expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Cryoglobulinemia Vasculitis |
Drug: Proleukin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | ANRS HC 21 VASCU IL-2, Evaluation of the Cellular Immune Response, Clinical Efficacy and Tolerance After IL-2 Therapy in HCV-Related Vasculitis Patients, Resistant to Conventional Therapy. |
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
it is a single arm study
|
Drug: Proleukin
3 millions IU/day from day 1 to 5 every 21 days will be carried out at W1, W3, W6, and W9)
|
A systemic Vasculitis is found in 5 to 10% of HCV infected patients with mixed cryoglobulinemia (MC). It mainly involves the skin, peripheral nerve and the kidney and may be life threatening (15% of death). Twenty to 30% of HCV-MC Vasculitis patients are resistant to conventional therapy (i.e. antiviral therapy and/or immunosuppressors) and still have an active disease. An antiviral therapy with Peg-interféron is generally prescribed to control Vasculitis lesions and to slow down the hepatic fibrosis progression. Thus, new therapeutic approaches are necessary in such patients. We recently described a CD4+ CD25+ regulatory T cell (Treg) deficiency in HCV-related Vasculitis patients. Immunomodulatory effects of interleukin-2 (IL-2) are well established, notably the preferential expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells.
Objective : To evaluate the cellular immune response after IL-2 therapy in HCV-MC Vasculitis patients, resistant to conventional therapy.
Methods : This is an open prospective phase I/II trial. Four cycle of subcutaneous IL-2 therapy (3 millions IU/day from day 1 to 5 every 21 days will be carried out at W1, W3, W6, and W9). The first cure will be carried out with half-dose of IL-2 (1.5 millions IU/day) in the hospital. If the tolerance is satisfactory, the later cures will be done ambulatory. All patients will be followed after IL-2 therapy (S11 to S37).
End points :
Schedule : Duration of patients' inclusion period is estimated 12 months. Duration of therapy and follow-up is estimated 9 months. Analysis of data will last 7 months. Overall duration: 28 months
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Patrice Cacoub, MD, PHD | +331 42 17 80 09 | patrice.cacoub@psl.aphp.fr |
| Contact: David SAADOUN, MD | +331 42 17 80 09 | dsadoun@wanadoo.fr |
| France | |
| Hôpital de la Pitié | Recruiting |
| Paris, France, 75651 | |
| Principal Investigator: Patrice Cacoub, MD, PHD | |
| Principal Investigator: | Patrice Cacoub, MD, PHD | Hôpital de la Pitié, 83 Bd de l'Hôpital 75651 Paris cedex 13 |
More Information
| Responsible Party: | Hôpital de la Pitié ( Pr Patrice Cacoub ) |
| Study ID Numbers: | 2006-004039-31, ANRS HC 21 Vascu-IL2 |
| Study First Received: | December 14, 2007 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00574652 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
HCV+ cryoglobulinemia Vasculitis IL-2 treatment safety and efficacy |
|
Aldesleukin Immunoproliferative Disorders Hemorrhagic Disorders Vasculitis Hematologic Diseases Blood Protein Disorders |
Blood Coagulation Disorders Cryoglobulinemia Vascular Diseases Paraproteinemias Hemostatic Disorders |
|
Immune System Diseases Cardiovascular Diseases |
