NCT00574652

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2008

Enrollment Period

2 years

First QC Date

December 14, 2007

Last Update Submit

January 23, 2013

Conditions

Cryoglobulinemia Vasculitis

Keywords

HCV+cryoglobulinemiaVasculitisIL-2 treatmentsafety and efficacy

Outcome Measures

Primary Outcomes (1)

  • Immunologic follow-up of Treg and of HCV cellular immune response before, during and after IL-2 therapy

    9 months

Secondary Outcomes (2)

  • Clinical tolerance: Absence of Vasculitis flare during and after IL-2 therapy

    9 months

  • Clinical efficacy: follow-up of clinical manifestations of HCV-MC

    9 months

Study Arms (1)

1

OTHER

it is a single arm study

Drug: Proleukin

Interventions

ProleukinDRUG

3 millions IU/day from day 1 to 5 every 21 days will be carried out at W1, W3, W6, and W9)

Also known as: Aldesleukin, Novartis Pharma S.A.S
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV+ patients with cryoglobulinemia Vasculitis
  • resistant to conventional therapy (i.e. antiviral therapy and/or immunosuppressors).
  • Vasculitis is defined according to international criteria: chronic HCV infection (HCV RNA+),
  • serum cryoglobulin superior or equal to 0.05g/l in at least two determinations,
  • presence of the triad purpura-arthralgia-asthenia and/or biopsy proven Vasculitis (kidney, nerve or skin).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Pitié

Paris, 75651, France

Location

Related Publications (1)

  • Saadoun D, Rosenzwajg M, Joly F, Six A, Carrat F, Thibault V, Sene D, Cacoub P, Klatzmann D. Regulatory T-cell responses to low-dose interleukin-2 in HCV-induced vasculitis. N Engl J Med. 2011 Dec 1;365(22):2067-77. doi: 10.1056/NEJMoa1105143.

    PMID: 22129253DERIVED

MeSH Terms

Conditions

CryoglobulinemiaVasculitis

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Patrice Cacoub, MD, PHD

    Hôpital de la Pitié, 83 Bd de l'Hôpital 75651 Paris cedex 13

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 17, 2007

Study Start

March 1, 2008

Primary Completion

March 1, 2010

Study Completion

September 1, 2010

Last Updated

January 24, 2013

Record last verified: 2008-01

Locations

FR(1)