Lamazym Aftercare Study
rhLAMAN-09
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
2 other identifiers
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2013
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedJuly 28, 2023
July 1, 2023
9.3 years
June 12, 2013
July 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in Adverse events
AE documented at all visits
3 year
Change from baseline in Lamazym antibodies
AB measured every 12th week
3 year
Secondary Outcomes (4)
progress from baseline in number of steps climbed in 3 minutes
1 year, 2 year and 3 year
Progress from baseline in equivalent age
1 year, 2 year and 3 year
Progress from baseline in Forced Vital Capacity
1 year, 2 year and 3 year
Progress from baseline in distance walked in 6 minutes
1 year, 2 year and 3 year
Study Arms (1)
Lamazym
EXPERIMENTAL1 mg Lamazym/kg body weight
Interventions
ERT, i.v. infusions weekly
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9
Copenhagen, DK-2100, Denmark
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2013
First Posted
July 26, 2013
Study Start
June 1, 2013
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
July 28, 2023
Record last verified: 2023-07