A Multi-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials

rhLAMAN-07

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.

2013-08-01

2022-09-30

2022-09-30

Completed

Early phase I

13

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}

2023-07-28