Overview

Lamazym Aftercare Study

Status:
Active, not recruiting
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 Lamazym i.v. treatment of subjects with alpha-Mannosidosis whom previously participated in Lamazym-trial.
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