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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 August 2023 |
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Main ID: |
NCT01908712 |
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Date of registration:
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16/07/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients
rhLAMAN-07 |
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Scientific title:
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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 |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01908712 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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)
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alpha-Mannosidosis
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Intervention(s)
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Drug: Lamazym
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Primary Outcome(s)
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Change from baseline in Adverse events
[Time Frame: 3 year]
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Change from baseline in Lamazym antibodies
[Time Frame: 3 year]
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Secondary Outcome(s)
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Progress from baseline in distance walked in 6 minutes
[Time Frame: 1 year, 2 year and 3 year]
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Progress from baseline in equivalent age
[Time Frame: 1 year, 2 year and 3 year]
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Progress from baseline in Forced Vital Capacity
[Time Frame: 1 year, 2 year and 3 year]
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progress from baseline in number of steps climbed in 3 minutes
[Time Frame: 1 year, 2 year and 3 year]
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Secondary ID(s)
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rhLAMAN-07
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2013-000336-97
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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