Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients

• Status: Enrolling by invitation
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.; Zymenex A/S

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)