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NCT01602601
A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723
trial testing Idursulfase in Mucopolysaccharidosis II in 10 participants. Completed in 11 June 2012.
11 June 2012
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 10 |
| Start date | 9 April 2012 |
| Primary completion | 11 June 2012 |
| Estimated completion | 11 June 2012 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Idursulfase (IDURSULFASE) — full drug profile →
- GSK2788723 — full drug profile →
Conditions studied
- Mucopolysaccharidosis II — all drugs for Mucopolysaccharidosis II →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Eligibility, any sex, with Mucopolysaccharidosis II. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study IDS116406 will be a non-interventional, phlebotomy study in Hunter Syndrome patients who are currently being treated with idursulfase, an enzyme replacement therapy, and in at least a single patient who is naïve to treatment, if possible to recruit. All patients enrolled into the study will have a single blood draw for the analysis of antibodies induced by this enzyme replacement therapy (idursulfase). Patient samples with positive responses to antibodies induced by idursulfase will be used to further evaluate whether the antibodies induced by idursulfase bind to GSK2788723 molecules in vitro and if these antibodies neutralize the bioactivity of GSK2788723 in vitro. Each subject will have a screening visit, which may occur at their regularly scheduled out-patient visit. If the patient consents to participate in the study, a blood sample (total volume of approximately 3mL) for immunogenicity analysis will be drawn before their current treatment infusion
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Polymer-based drug delivery systems under investigation for enzyme replacement and other therapies of lysosomal storage disorders.
Placci M, Giannotti MI, Muro S. · · 2023 · cited 14× · PMID 36657645 · DOI 10.1016/j.addr.2022.114683
Verify or expand the search:
- PubMed search for NCT01602601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Idursulfase
Trials testing the same drug.
- NCT04573023 — A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) · Phase 3 · active not recruiting
- NCT00882921 — An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients · completed
- NCT00607386 — Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy · Phase 4 · completed
- NCT00630747 — Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase · Phase 2, PHASE3 · completed
Other recruiting trials for Mucopolysaccharidosis II
Currently open trials in the same condition.
- NCT05619900 — Registry of Patients Diagnosed With Lysosomal Storage Diseases · recruiting
- NCT04573023 — A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) · Phase 3 · active not recruiting
- NCT04628871 — Long Term Follow-up (LTFU) of Subjects Who Received SB-318, SB-913, or SB-FIX · active not recruiting
- NCT04348136 — An Extension Study of JR-141 in Patients With Mucopolysaccharidosis Type II · Phase 2, PHASE3 · active not recruiting
- NCT03708965 — An Extension Study of JR-141-BR21 in Patients With Mucopolysaccharidosis II · Phase 2 · active not recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01602601 (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 GlaxoSmithKline
- Last refreshed: 25 September 2017
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/NCT01602601.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing