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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR GUSPERIMUS

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Clinical Trials for Gusperimus

Trial ID Title Status Sponsor Phase Summary
NCT00530075 Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis Completed Nippon Kayaku Co.,Ltd. Phase 2 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 Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to clinical status.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.
NCT00709722 Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis Completed Nippon Kayaku Co.,Ltd. Phase 1/Phase 2 The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
NCT01052259 Efficacy and Safety of Deoxyspergualin in Renal Transplant Patient With Chronic Rejection Terminated Nippon Kayaku Co.,Ltd. N/A The purpose of this study to examine the efficacy and safety of cycling treatment of deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection.
NCT01446211 Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis Terminated Nordic Pharma SAS Phase 3 The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared to conventional treatment in patients with a relapse of Wegener Granulomatosis with or without ongoing steroids, and/or immunosuppressive therapy. Further, to evaluate the safety and quality of life of gusperimus treatment compared to standard treatment in patients with relapse of Wegener Granulomatosis receiving glucocorticoids.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Gusperimus

Condition Name

Condition Name for
Intervention Trials
Chronic Rejection 1
Wegeners Granulomatosis 1
Wegener's Granulomatosis 1
Lupus Nephritis 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Granulomatosis with Polyangiitis 2
Nephritis 1
Lupus Nephritis 1
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Clinical Trial Locations for Gusperimus

Trials by Country

Trials by Country for
Location Trials
Japan 5
Czech Republic 3
Germany 2
United Kingdom 2
Netherlands 1
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Clinical Trial Progress for Gusperimus

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 1
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 2
Terminated 2
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Clinical Trial Sponsors for Gusperimus

Sponsor Name

Sponsor Name for
Sponsor Trials
Nippon Kayaku Co.,Ltd. 3
Nordic Pharma SAS 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 4
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