Status:
COMPLETED
Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Alpha-Mannosidosis
Eligibility:
All Genders
Phase:
PHASE3
Brief 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.
Detailed Description
This trial provide aftercare treatment with Lamzede to French patients.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01908712
Start Date
August 1 2013
End Date
September 30 2022
Last Update
July 28 2023
Active Locations (1)
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1
Hôpital Femme Mére Enfant - CHU de Lyon
Bron, France, F-69677