Hôpital Femme Mére Enfant - CHU de Lyon
Bron, F-69677, France
NCT Number: NCT01908712
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.
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Interventional
Phase 3
Bron, F-69677, France
This trial provide aftercare treatment with Lamzede to French patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ERT, i.v. infusions weekly
Other names: rhLAMAN, recombinant human alpha-mannosidase
Time frame: 3 year
AE documented at every visit
Time frame: 3 year
AB measured every 12th week
Time frame: 1 year, 2 year and 3 year
Time frame: 1 year, 2 year and 3 year
Time frame: 1 year, 2 year and 3 year
Time frame: 1 year, 2 year and 3 year
Chiesi Farmaceutici S.p.A.
Industry
A Multi-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials
Acronym: rhLAMAN-07
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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