Who is sponsoring NCT00048711?

NCT00048711 is sponsored by BioMarin Pharmaceutical.

What condition does NCT00048711 study?

NCT00048711 studies Mucopolysaccharidosis VI.

What drugs are being tested in NCT00048711?

Interventions: N-acetylgalactosamine 4-sulfatase.

What is the status of NCT00048711?

NCT00048711 is currently COMPLETED.

Last reviewed 2009-08-24 · How we verify

Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients With MPS VI

NCT00048711 Phase 2 COMPLETED

The purpose of the study is evaluate the efficacy, safety, and pharmacokinetics of weekly intravenous infusions of 1 mg/kg recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) in patients diagnosed with Mucopolysaccharidosis VI (MPS VI)

Details

Lead sponsor	BioMarin Pharmaceutical
Phase	Phase 2
Status	COMPLETED
Start date	2002-03
Completion	2006-06

Conditions

Mucopolysaccharidosis VI

Interventions

N-acetylgalactosamine 4-sulfatase

Primary outcomes

12-minute walk test — weeks 6, 12, 24, 48, 96 and 144
urinary glycoaminoglycan(uGAG)levels — weeks 1, 4, 6, 8, 12

Countries

United States