Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients

Brief Title

Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients

Official Title

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

Brief Summary

      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.
    

Detailed Description

      This trial provide aftercare treatment with Lamzede to French patients.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change from baseline in Adverse events

Secondary Outcome

 progress from baseline in number of steps climbed in 3 minutes

Condition

Alpha-Mannosidosis

Intervention

Lamazym

Study Arms / Comparison Groups

 Lamazym
Description:  1 mg Lamazym/kg body weight

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

August 2013

Completion Date

March 2023

Primary Completion Date

September 2022

Eligibility Criteria

        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)
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01908712

Organization ID

rhLAMAN-07

Secondary IDs

2013-000336-97

Responsible Party

Sponsor

Study Sponsor

Chiesi Farmaceutici S.p.A.


Study Sponsor

, , 


Verification Date

July 2022