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Completed

NCT Number: NCT01908712

Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients

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.

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Key information

About this study

This trial provide aftercare treatment with Lamzede to French patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lamazym

Drug

ERT, i.v. infusions weekly

Other names: rhLAMAN, recombinant human alpha-mannosidase

Primary outcomes

  1. Change from baseline in Adverse events

    Time frame: 3 year

    AE documented at every visit

  2. Change from baseline in Lamazym antibodies

    Time frame: 3 year

    AB measured every 12th week

Secondary outcomes

  1. progress from baseline in number of steps climbed in 3 minutes

    Time frame: 1 year, 2 year and 3 year

  2. Progress from baseline in equivalent age

    Time frame: 1 year, 2 year and 3 year

  3. Progress from baseline in Forced Vital Capacity

    Time frame: 1 year, 2 year and 3 year

  4. Progress from baseline in distance walked in 6 minutes

    Time frame: 1 year, 2 year and 3 year

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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

Acronym: rhLAMAN-07

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2013
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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