Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients

Study Identifier:
rhLAMAN-07
ClinicalTrials.gov Identifier:
NCT01908712
EudraCT Identifier:
2013-000336-97
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Plain Language Summary
Available Languages: English, French, Albanian
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Study Details

Medical Condition
  • Alpha-mannosidosis
Study Drug
  • Drug: Lamazym
Date
Aug 2013 - Sep 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • the subject must have participated in previous Lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17
  • Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities
  • The subject and his/her guardian(s) must have the ability to comply with the protocol
Exclusion Criteria
  • Presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
  • Any other medical condition or serious intercurrent illness, or extenuating circumstances that, in the opinion of the Investigator, would preclude participation in the trial
  • Pregnancy. Pregnant woman is excluded. Before start fot he treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception
  • Psychosis; any psychotic disease, also in remission, is an exclusion criteria
  • Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial
  • Adult patients who, in the opinion of the Investigator, would be unable to give consent, and who does not have any legal protection or guardianship
  • total IgE \> 800 IU/mL
  • Known allergy to the IMP or any excipients (Sodium-Phosphate, Glycine, Mannitol)
Healthy Volunteers
No

Protocol Summary

The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamzede i.v. treatment of subjects with alpha-Mannosidosis.

Study Locations

Location
Status
Location
Hôpital Femme Mére Enfant - CHU de Lyon
Bron, France, F-69677
Status
N/A