- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01908725
Lamazym Aftercare Study (rhLAMAN-09)
July 26, 2023 updated by: Chiesi Farmaceutici S.p.A.
A Single-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
The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamazym i.v.
treatment of subjects with alpha-Mannosidosis whom previously participated in Lamazym-trial.
Study Overview
Detailed Description
This protocol only concern subjects where compassionate use program was not accepted.
Efficacy will be evaluated once yearly to follow the subject's progress in clinical parameters.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, DK-2100
- Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lamazym
1 mg Lamazym/kg body weight
|
ERT, i.v. infusions weekly
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Adverse events
Time Frame: 3 year
|
AE documented at all visits
|
3 year
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Change from baseline in Lamazym antibodies
Time Frame: 3 year
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AB measured every 12th week
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3 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progress from baseline in number of steps climbed in 3 minutes
Time Frame: 1 year, 2 year and 3 year
|
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
|
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
|
1 year, 2 year and 3 year
|
Progress from baseline in distance walked in 6 minutes
Time Frame: 1 year, 2 year and 3 year
|
1 year, 2 year and 3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
June 12, 2013
First Submitted That Met QC Criteria
July 23, 2013
First Posted (Estimated)
July 26, 2013
Study Record Updates
Last Update Posted (Actual)
July 28, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rhLAMAN-09
- 2013-000321-31 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alpha-Mannosidosis
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Zymenex A/SEuropean CommissionUnknown
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Zymenex A/SEuropean CommissionCompleted
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Zymenex A/SEuropean CommissionCompletedAlpha MannosidosisCzechia, Germany, Norway, United Kingdom
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CENTOGENE GmbH RostockWithdrawnAlpha-Mannosidase B Deficiency | Lysosomal Alpha B Mannosidosis | Alpha-Mannosidase DeficiencyIndia, Sri Lanka, Germany
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Chiesi Farmaceutici S.p.A.CompletedAlpha-MannosidosisFrance
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Zymenex A/SEuropean CommissionCompletedA Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-MannosidosisAlpha-MannosidosisDenmark, United Kingdom, France, Germany, Poland
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Chiesi Farmaceutici S.p.A.Not yet recruiting
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Chiesi Farmaceutici S.p.A.CromsourceCompletedAlpha-MannosidosisFrance, Denmark, Austria, Germany, Italy
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Chiesi Farmaceutici S.p.A.Withdrawn
Clinical Trials on Lamazym
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Chiesi Farmaceutici S.p.A.CromsourceCompletedAlpha-MannosidosisFrance, Denmark, Austria, Germany, Italy
-
Zymenex A/SEuropean CommissionCompleted
-
Zymenex A/SEuropean CommissionUnknown
-
Zymenex A/SCompleted
-
Chiesi Farmaceutici S.p.A.CompletedAlpha-MannosidosisFrance
-
Zymenex A/SEuropean CommissionCompletedAlpha-MannosidosisBelgium, Denmark, Spain, United Kingdom
-
Zymenex A/SEuropean CommissionCompletedA Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-MannosidosisAlpha-MannosidosisDenmark, United Kingdom, France, Germany, Poland