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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: January 16, 2017
Last verified: September 2007
Results First Received: April 18, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Wegener's Granulomatosis
Intervention: Drug: Gusperimus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 7 sites in 6 European countries from 2003 to 2006

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gusperimus SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles

Participant Flow:   Overall Study
    Gusperimus
STARTED   45 
COMPLETED   38 
NOT COMPLETED   7 
Adverse Event                1 
Death                1 
Lack of Efficacy                3 
Protocol Violation                1 
Withdrawal by Subject                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gusperimus SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles

Baseline Measures
   Gusperimus 
Overall Participants Analyzed 
[Units: Participants]
 45 
Age 
[Units: Years]
Median (Full Range)
 51 
 (19 to 77) 
Gender 
[Units: Participants]
Count of Participants
 
Female      16  35.6% 
Male      29  64.4% 
Region of Enrollment 
[Units: Participants]
 
Europe   45 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Remission of Vasculitis   [ Time Frame: At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks ]

2.  Secondary:   Duration of Clinical Response   [ Time Frame: At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks, End of treatment period, and 3 and 6 months of follow-up period ]

3.  Secondary:   Haematuria   [ Time Frame: At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks ]

4.  Secondary:   Creatinine   [ Time Frame: At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks ]

5.  Secondary:   ANCA   [ Time Frame: At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks ]

6.  Secondary:   CRP   [ Time Frame: At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks ]

7.  Secondary:   Vasculitis Damage Index (VDI)   [ Time Frame: At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks, 6 months of follow-up period ]

8.  Secondary:   SF-36   [ Time Frame: At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pharmaceuticals Group
Organization: Nippon Kayaku Co., Ltd.
phone: +81-3-6731-5200


Publications:

Responsible Party: Peter A. Heinzel, Ph.D., Clinical and Scientific Department, Euro Nippon Kayaku GmbH
ClinicalTrials.gov Identifier: NCT00530075     History of Changes
Other Study ID Numbers: 102
Study First Received: September 14, 2007
Results First Received: April 18, 2016
Last Updated: January 16, 2017