China Post-marketing Surveillance (PMS) Study of Aldurazyme®

    Not Recruiting
  • End date
    Jul 26, 2023
  • participants needed
  • sponsor
    Genzyme, a Sanofi Company
Updated on 24 March 2023


This is a single treatment arm study that is open-label to be conducted in Chinese participants with MPS I.

Trial Objectives are to evaluate the safety and tolerability of Aldurazyme in Chinese MPS I participants, and to evaluate the efficacy of Aldurazyme on the percent change of urinary glycosaminoglycans (uGAGs) from baseline to Week 26. The study will also evaluate the effect on uGAG level and liver volume (hepatomegaly) after 26 weeks, with Aldurazyme treatment in Chinese MPS I participants.

Treatment duration will include: 2 weeks of screening, 26 weeks of treatment and 1 week of follow-up period. During the treatment period, weekly visits are designed to accommodate weekly administration of Aldurazyme (laronidase).


Study duration for each participant will be a total of 29 weeks which will include 2 weeks of screening, 26 weeks of treatment period and 1 week of follow-up period.

Condition Mucopolysaccharidosis I
Treatment Laronidase
Clinical Study IdentifierNCT05134571
SponsorGenzyme, a Sanofi Company
Last Modified on24 March 2023

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