Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients (rhLAMAN-07)

Chiesi

Status and phase

Completed

Phase 3

Conditions

Alpha-Mannosidosis

Treatments

Drug: Lamazym

Study type

Interventional

Funder types

Industry

Identifiers

NCT01908712

2013-000336-97 (EudraCT Number)

rhLAMAN-07

Details and patient eligibility

About

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.

Full description

This trial provide aftercare treatment with Lamzede to French patients.

Enrollment

13 patients

Sex

All

Volunteers

No Healthy Volunteers

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)