A trial of the long-term safety of Lamazym aftercare treatment of subjects with alpha-Mannosidosis who previously participated in Lamazym-trials

Phase 1

• Conditions: Alpha-Mannosidosis; MedDRA version: 20.0Level: LLTClassification code 10032658Term: Other specified disorders of carbohydrate transport and metabolismSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-000336-97-DK
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. The subject must have participated in previous Lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17
2. Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities
3. 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: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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
2. Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial
3. Pregnancy: Pregnant women are excluded. Before start of the treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception
4. Psychosis; any psychotic disease, also in remission, is an exclusion criteria
5. Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial
6. 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
7. Total IgE >800 IU/mL
8. Known allergy to the IMP or any excipients (Sodium-Phosphate, Glycine, Mannitol)

Study & Design

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