Clinical Trial: Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Single-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated

Brief Summary: The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis whom previously participated in Lamazym-trial.

Detailed Summary: This trial provide aftercare treatment with Lamazym to French patients.
Sponsor: Zymenex A/S

Current Primary Outcome:

  • Change from baseline in Adverse events [ Time Frame: 3 year ]
    AE documented at every visit
  • Change from baseline in Lamazym antibodies [ Time Frame: 3 year ]
    AB measured every 12th week


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • progress from baseline in number of steps climbed in 3 minutes [ Time Frame: 1 year, 2 year and 3 year ]
  • Progress from baseline in equivalent age [ Time Frame: 1 year, 2 year and 3 year ]
  • Progress from baseline in Forced Vital Capacity [ Time Frame: 1 year, 2 year and 3 year ]
  • Progress from baseline in distance walked in 6 minutes [ Time Frame: 1 year, 2 year and 3 year ]


Original Secondary Outcome: Same as current

Information By: Chiesi Farmaceutici S.p.A.

Dates:
Date Received: July 16, 2013
Date Started: August 2013
Date Completion: December 2018
Last Updated: September 1, 2016
Last Verified: September 2016