Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-02-04 @ 8:28 PM
Study NCT ID:
NCT01908712
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2013-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008363', 'term': 'alpha-Mannosidosis'}], 'ancestors': [{'id': 'D044904', 'term': 'Mannosidase Deficiency Diseases'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2013-07-16', 'studyFirstSubmitQcDate': '2013-07-23', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Adverse events', 'timeFrame': '3 year', 'description': 'AE documented at every visit'}, {'measure': 'Change from baseline in Lamazym antibodies', 'timeFrame': '3 year', 'description': 'AB measured every 12th week'}], 'secondaryOutcomes': [{'measure': 'progress from baseline in number of steps climbed in 3 minutes', 'timeFrame': '1 year, 2 year and 3 year'}, {'measure': 'Progress from baseline in equivalent age', 'timeFrame': '1 year, 2 year and 3 year'}, {'measure': 'Progress from baseline in Forced Vital Capacity', 'timeFrame': '1 year, 2 year and 3 year'}, {'measure': 'Progress from baseline in distance walked in 6 minutes', 'timeFrame': '1 year, 2 year and 3 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alpha-Mannosidosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.google.dk/url?sa=t&rct=j&q=line%20borgwardt&source=web&cd=1&cad=rja&sqi=2&ved=0CCsQtwIwAA&url=http%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DZGgqK7oJQFQ&ei=4TG4UejWD8SSO7TqgbAI&usg=AFQjCNG4azVFYvyGp-yNBeoP4tG6YQQ1Tw&bvm=bv.47810305,d.ZWU', 'label': '12th international symposium on MPS and related diseases'}, {'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-000336-97/results', 'label': 'Results posted in EudraCT'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This trial provide aftercare treatment with Lamzede to French patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the subject must have participated in previous Lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17\n* Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities\n* The subject and his/her guardian(s) must have the ability to comply with the protocol\n\nExclusion Criteria:\n\n* 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\n* Any other medical condition or serious intercurrent illness, or extenuating circumstances that, in the opinion of the Investigator, would preclude participation in the trial\n* 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\n* Psychosis; any psychotic disease, also in remission, is an exclusion criteria\n* Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial\n* 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\n* total IgE \\> 800 IU/mL\n* Known allergy to the IMP or any excipients (Sodium-Phosphate, Glycine, Mannitol)'}, 'identificationModule': {'nctId': 'NCT01908712', 'acronym': 'rhLAMAN-07', 'briefTitle': 'Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'rhLAMAN-07'}, 'secondaryIdInfos': [{'id': '2013-000336-97', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lamazym', 'description': '1 mg Lamazym/kg body weight', 'interventionNames': ['Drug: Lamazym']}], 'interventions': [{'name': 'Lamazym', 'type': 'DRUG', 'otherNames': ['rhLAMAN', 'recombinant human alpha-mannosidase'], 'description': 'ERT, i.v. infusions weekly', 'armGroupLabels': ['Lamazym']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'F-69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Femme Mére Enfant - CHU de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}