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Lamazym Aftercare Study (rhLAMAN-09)

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Chiesi

Status and phase

Completed
Phase 3

Conditions

Alpha-Mannosidosis

Treatments

Drug: Lamazym

Study type

Interventional

Funder types

Industry

Identifiers

NCT01908725
2013-000321-31 (EudraCT Number)
rhLAMAN-09

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Lamazym
Experimental group
Description:
1 mg Lamazym/kg body weight
Treatment:
Drug: Lamazym

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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