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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01908712
Other study ID # rhLAMAN-07
Secondary ID 2013-000336-97
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2013
Est. completion date September 30, 2022

Study information

Verified date July 2023
Source Chiesi Farmaceutici S.p.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This trial provide aftercare treatment with Lamzede to French patients.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lamazym
ERT, i.v. infusions weekly

Locations

Country Name City State
France Hôpital Femme Mére Enfant - CHU de Lyon Bron

Sponsors (1)

Lead Sponsor Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Adverse events AE documented at every visit 3 year
Primary Change from baseline in Lamazym antibodies AB measured every 12th week 3 year
Secondary progress from baseline in number of steps climbed in 3 minutes 1 year, 2 year and 3 year
Secondary Progress from baseline in equivalent age 1 year, 2 year and 3 year
Secondary Progress from baseline in Forced Vital Capacity 1 year, 2 year and 3 year
Secondary Progress from baseline in distance walked in 6 minutes 1 year, 2 year and 3 year
See also
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Not yet recruiting NCT06184503 - Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3
Completed NCT01908725 - Lamazym Aftercare Study Phase 3
Completed NCT02141503 - Clinical Biomarkers in Alpha-mannosidosis
Recruiting NCT02171104 - MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis Phase 2
Completed NCT01681940 - Long-term Efficacy and Safety of Lamazym for the Treatment of Patients With Alpha-Mannosidosis Phase 2
Withdrawn NCT04031066 - Interventional Study to Assess Efficacy and Safety of Velmanase Alfa in Patients With Alpha Mannosidosis Phase 3
Recruiting NCT03333200 - Longitudinal Study of Neurodegenerative Disorders
Completed NCT02478840 - Evaluation of Long-term Efficacy of Treatment With Lamazym Phase 3
Completed NCT02998879 - Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis Phase 2
Completed NCT01681953 - A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis Phase 3
Terminated NCT01372228 - Phase I/II Pilot Study of Mixed Chimerism to Treat Inherited Metabolic Disorders Phase 1/Phase 2
Available NCT04959240 - Expanded Access to Velmanase Alfa