NCT01908725 (rhLAMAN-09) is a Phase 3 clinical trial of Lamazym in Alpha-Mannosidosis, sponsored by Chiesi Farmaceutici S.p.A..

Who is sponsoring NCT01908725?

NCT01908725 is sponsored by Chiesi Farmaceutici S.p.A..

What drugs are being tested in NCT01908725?

Interventions in NCT01908725: Lamazym.

What condition does NCT01908725 study?

NCT01908725 studies Alpha-Mannosidosis.

Is NCT01908725 still recruiting?

NCT01908725 is currently completed. Last updated 26 July 2023.

Last reviewed 2023-07-26 · How we verify

NCT01908725: rhLAMAN-09

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 26 July 2023

What this trial tests

Phase 3 trial testing Lamazym in Alpha-Mannosidosis in 8 participants. Completed in 30 September 2022.

Timeline

1 June 2013

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 June 2013
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	1 location across Denmark

Drugs / interventions tested

Lamazym — full drug profile →

Conditions studied

Alpha-Mannosidosis — all drugs for Alpha-Mannosidosis →

Sponsor

Chiesi Farmaceutici S.p.A. — full company profile →

Who can join

Eligibility, any sex, with Alpha-Mannosidosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from baseline in Adverse events
Time frame: 3 year
AE documented at all visits
Change from baseline in Lamazym antibodies
Time frame: 3 year
AB measured every 12th week

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial.
Borgwardt L, Guffon N, Amraoui Y, Dali CI, et al · · 2018 · cited 43× · PMID 29846843 · DOI 10.1007/s10545-018-0185-0
Comprehensive long-term efficacy and safety of recombinant human alpha-mannosidase (velmanase alfa) treatment in patients with alpha-mannosidosis.
Lund AM, Borgwardt L, Cattaneo F, Ardigò D, et al · · 2018 · cited 35× · PMID 29725868 · DOI 10.1007/s10545-018-0175-2
Extended long-term efficacy and safety of velmanase alfa treatment up to 12 years in patients with alpha-mannosidosis.
Guffon N, Borgwardt L, Tylki-Szymańska A, Ballabeni A, et al · · 2025 · cited 6× · PMID 39381850 · DOI 10.1002/jimd.12799
Relationship between <i>MAN2B1</i> genotype/subcellular localization subgroups, antidrug antibody detection, and long-term velmanase alfa treatment outcomes in patients with alpha-mannosidosis.
Borgwardt LG, Ceravolo F, Zardi G, Ballabeni A, et al · · 2023 · cited 5× · PMID 36873087 · DOI 10.1002/jmd2.12349
Velmanase alfa approved for treatment of non-central nervous system manifestations of alpha-mannosidosis: A therapeutics bulletin of the American College of Medical Genetics and Genomics (ACMG).
Lander JM, Penon-Portmann M, Sutton VR, Chang I, et al · · 2024 · PMID 39669629 · DOI 10.1016/j.gimo.2024.101832

Verify or expand the search:

Other recruiting trials for Alpha-Mannosidosis

Currently open trials in the same condition.

NCT02171104 — MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis · Phase 2 · active not recruiting

Other Chiesi Farmaceutici S.p.A. trials

Trials by the same sponsor.

NCT07516951 — A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis · Phase 2 · not yet recruiting
NCT07301736 — Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma · Phase 2 · recruiting
NCT07163182 — Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and · Phase 1 · recruiting
NCT06900816 — A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate C · Phase 2 · completed
NCT06892756 — Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01908725 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chiesi Farmaceutici S.p.A.
Last refreshed: 26 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01908725.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing