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A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis

NCT01681953 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-08-03

No results posted yet for this study

Summary

The overall objective of this trial is to evaluate the efficacy and safety of repeated Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with alpha-Mannosidosis

Conditions

  • Alpha-Mannosidosis

Interventions

DRUG

Lamazym

ERT, i.v. infusions weekly

DRUG

Placebo

Infusions weekly

Sponsors & Collaborators

Principal Investigators

  • Allan M Lund, MD · Copenhagen University Hospital, Center for Metabolic Diseases, Department for Clinical Genetics

  • Jens Fogh · Zymenex A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Denmark
  • France
  • Germany
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01681953 on ClinicalTrials.gov