Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis

This study has been completed.
Sponsor:
Information provided by:
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00530075
First received: September 14, 2007
Last updated: February 13, 2008
Last verified: September 2007

September 14, 2007
February 13, 2008
December 2003
February 2006   (final data collection date for primary outcome measure)
Remission (defined by Birmingham Vasculitis Activity Score (BVAS)) [ Time Frame: Screening, Day1 of Cycle1, End of each cycle ] [ Designated as safety issue: No ]
Remission (defined by Barmingham Vasculitis Activity Score (BVAS)) [ Time Frame: Screening, Day1 of Cycle1, End of each cycle ]
Complete list of historical versions of study NCT00530075 on ClinicalTrials.gov Archive Site
Duration of clinical response, Laboratory markers (CRP, ESR, urine-analysis, ANCA), Damage as measured by the Vasculitis Damage Index, Patient function as measured by the SF-36 score, Adverse events [ Time Frame: Screening, Day1 of Cycle1, End of each cycle; for Adverse events, throughaout study period ] [ Designated as safety issue: Yes ]
Duration of clinical response, Laboratory markers (CRP, ESR, urine-analysis, ANCA), Damage as measured by the Vasculitis Damage Index, Patient function as measyred by the SF-36 score, Adverse events [ Time Frame: Screening, Day1 of Cycle1, End of each cycle; for Adverse events, throughaout study period ]
Not Provided
Not Provided
 
Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis
Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis

Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys. Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible damage due to the disease and the consequences of prolonged drug exposure. The efficacy and safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with refractory disease. A prospective, international, nulti-centre, single limb, open label study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity Score (BVAS) >=4 and previous therapy with cyclophosphamide or methotrexate. Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped early for white blood count < 4,000/mm3. The primary endpoint was complete remission (BVAS=0 for at least 2 months) or partial remission (BVAS<50% of entry score). After the sixth cycle azathioprine was commenced and follow-up continued for a further six months.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Wegener's Granulomatosis
Drug: Gusperimus
SC, 0.5mg/kg/day, consecutive 21 days administration, 1 to 2 weeks rest, 6 cycles
Experimental: 1
Gusperimus
Intervention: Drug: Gusperimus
Birck R, Warnatz K, Lorenz HM, Choi M, Haubitz M, Grunke M, Peter HH, Kalden JR, Gobel U, Drexler JM, Hotta O, Nowack R, Van Der Woude FJ. 15-Deoxyspergualin in patients with refractory ANCA-associated systemic vasculitis: a six-month open-label trial to evaluate safety and efficacy. J Am Soc Nephrol. 2003 Feb;14(2):440-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
February 2006
February 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented diagnosis of WG according to American College of Rheumatology (ACR) and Chapel Hill Consensus Conference (CHCC) definition
  • BVAS >= 4
  • Total disease duration >= 3 months treated with CYC or >= 6 months with MTX
  • Age 18 - 80
  • WBC >= 4,000/mm3, haemoglobin >= 8g/dl, neutrophils >= 2,500/mm3, platelets >= 100,000/mm3
  • ALT, bilirubin and alkaline phosphatase levels within 2x the upper limits of normal
  • Documented to be non-pregnant by serum/urine pregnancy test
  • Willing to participate in this study
  • Provide signed informed consent
  • Able and prepared to self-administer the study drug or have a close friend/relative able to do this

Exclusion Criteria:

  • Participation in another clinical research study
  • Pregnant or nursing mothers and women of childbearing age not using appropriate contraception
  • Clear evidence of active disease due to bacteria/viral infection
  • Patient has an unacceptable risk for participation in a study of immunosuppressive therapy
  • History of substance abuse or psychotic disorders
  • Previous treatment with Gusperimus
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Czech Republic,   Sweden,   Denmark,   Germany,   Netherlands
 
NCT00530075
102
No
Peter A. Heinzel, Ph.D., Clinical and Scientific Department, Euro Nippon Kayaku GmbH
Nippon Kayaku Co.,Ltd.
Not Provided
Principal Investigator: David Jayne Addenbrookes Hospital
Nippon Kayaku Co.,Ltd.
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP