A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis.

• Conditions: Treatement of Alpha-Mannosidosis; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-004355-40-GB
• Lead Sponsor: Zymenex A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-14
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

The subject must have participated in the phase 1 trial (EudraCT number: 2010-022084-36) and phase 2a trial (EudraCT number: 2010-022085-26)
Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject)
The subject and his/her guardian(s) must have the ability to comply with the protocol

Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The subject cannot walk without support
Presence of known chromosomal abnormality and syndromes affecting psychomotor development, other than alpha-Mannosidosis
History of bone marrow transplantation
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 circumstance that, in the opinion of the investigator, would preclude participation in the trial.
Pregnancy
Psychosis within the last 3 months
Planned major surgery that, in the opinion of the investigator, would preclude participation in the trial
Participation in other interventional trials testing IMP except for studies with Lamazym

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified