12 completed, 5 terminated, 1 recruiting. 6 Phase 1, 4 Phase 4, 3 Phase 2, 3 Phase 3, 2 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 3, Terminated 2, Recruiting 1 |
| Phase 4 | 4 | Completed 3, Terminated 1 |
| Phase 2 | 3 | Completed 3 |
| Phase 3 | 3 | Completed 3 |
| Not applicable | 2 | Completed 1, Terminated 1 |
Follow Iduronidase: new trials by email Literature Review of Iduronidase trials Research Report on Iduronidase
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of YW17 (Laronidase-CinnaGen) Compared to Aldurazyme® in MPS I Patients Laronidase, Antihistamine, Antipyretic - Mucopolysaccharidosis Type 1 | Phase 3 | Completed | Cinnagen | 12 | 2022-09-10 | 2024-08-06 |
| China Post-marketing Surveillance (PMS) Study of Aldurazyme® Laronidase - Mucopolysaccharidosis I | Phase 4 | Completed | Genzyme, a Sanofi Company | 12 | 2021-10-28 | 2025-09-17 |
| PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders) Aldurazyme (laronidase) - MPS I, MPS II | Phase 1 | Recruiting | University of California, San Francisco | 10 | 2021-07-01 | 2026-03-17 |
| Extension Study of Intrathecal Enzyme Replacement for Cognitive Decline in MPS I Intrathecal recombinant human alpha iduronidase - Mucopolysaccharidosis I, Cognitive Decline | Not applicable | Terminated | agnes chen | 6 | 2014-08-01 | 2023-10-31 |
| Administration of IV Laronidase Post Bone Marrow Transplant in Hurler Laronidase - Hurler Syndrome | Phase 1 | Completed | Masonic Cancer Center, University of Minnesota | 11 | 2012-05-29 | 2020-03-20 |
| Laronidase (Aldurazyme TM) Enzyme Replacement Therapy With Hematopoietic Stem Cell Transplant for Hurler Syndrome Laronidase - Mucopolysaccharidosis Type IH, MPS I | Terminated | Masonic Cancer Center, University of Minnesota | 20 | 2012-03-28 | 2018-09-27 | |
| A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants Laronidase - Mucopolysaccharidosis I, Hurler's Syndrome | Phase 4 | Terminated | Genzyme, a Sanofi Company | 2 | 2010-10-22 | 2024-02-20 |
| A Study of Intrathecal Enzyme Therapy for Cognitive Decline in MPS I laronidase - Cognitive Decline, Mucopolysaccharidosis I | Not applicable | Completed | Patricia I. Dickson, M.D. | 9 | 2009-06-01 | 2016-01-26 |
| Immune Tolerance Study With Aldurazyme® (Laronidase) Laronidase, Cyclosporine A (CsA), Azathioprine (Aza) - Mucopolysaccharidosis I | Phase 1 / Phase 2 | Completed | Genzyme, a Sanofi Company | 7 | 2008-09-01 | 2014-07-02 |
| Intrathecal Enzyme Replacement for Hurler Syndrome IRT Laronidase - Hurler Syndrome | Phase 1 | Completed | Masonic Cancer Center, University of Minnesota | 26 | 2008-01-02 | 2018-12-03 |
| Extension Study of Intrathecal Enzyme Replacement Therapy for MPS I laronidase - Spinal Cord Compression, Mucopolysaccharidosis I | Phase 1 | Terminated | Patricia I. Dickson, M.D. | 3 | 2008-01-01 | 2013-02-21 |
| Study of Aldurazyme® Replacement Therapy in Patients With Mucopolysaccharidosis I (MPS I) Disease Aldurazyme (Recombinant Human Alpha-L-Iduronidase) - Mucopolysaccharidosis I, Hurler Syndrome | Phase 3 | Completed | Genzyme, a Sanofi Company | 3 | 2005-12-01 | 2014-03-07 |
| Intrathecal Enzyme Replacement Therapy for Spinal Cord Compression in Mucopolysaccharidosis (MPS) I laronidase - Mucopolysaccharidosis I, Lysosomal Storage Diseases | Phase 1 | Terminated | Patricia I. Dickson, M.D. | 4 | 2005-11-01 | 2013-02-21 |
| A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease Aldurazyme (Recombinant Human Alpha-L-Iduronidase) - Mucopolysaccharidosis I, Hurler's Syndrome | Phase 4 | Completed | Genzyme, a Sanofi Company | 34 | 2004-12-01 | 2015-04-03 |
| A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients laronidase - Mucopolysaccharidosis I, Hurler's Syndrome | Phase 4 | Completed | Genzyme, a Sanofi Company | 25 | 2004-07-01 | 2014-05-05 |
| Stem Cell Transplant w/Laronidase for Hurler Stem Cell Transplant, Laronidase ERT - Mucopolysaccharidosis I, Hurler Syndrome | Phase 2 | Completed | Masonic Cancer Center, University of Minnesota | 25 | 2004-03-01 | 2019-07-11 |
| A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase) in MPS I Patients Less Than 5 Years Old Aldurazyme (Recombinant Human Alpha-L-Iduronidase) - Mucopolysaccharidosis I, Hurler Syndrome | Phase 2 | Completed | Genzyme, a Sanofi Company | 20 | 2002-10-01 | 2015-04-03 |
| Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients Aldurazyme, placebo - Mucopolysaccharidosis I, Hurler's Syndrome | Phase 3 | Completed | Genzyme, a Sanofi Company | 45 | 2001-05-01 | 2015-04-03 |
Mucopolysaccharidosis I (17) · Mucopolysaccharidoses (4) · Lysosomal Storage Diseases (3) · Cognitive Dysfunction (2) · Spinal Cord Compression (2) · Gaucher Disease (1) · Metabolism, Inborn Errors (1) · Mucopolysaccharidosis IV (1) · Mucopolysaccharidosis VI (1) · Mucopolysaccharidosis VII (1) · Sudden Infant Death (1) · Wolman Disease (1)
Genzyme, a Sanofi Company (8) · Masonic Cancer Center, University of Minnesota (4) · Patricia I. Dickson, M.D. (3) · Cinnagen (1) · University of California, San Francisco (1) · agnes chen (1)
United States (11) · Brazil (3) · Canada (2) · Finland (2) · Germany (2) · Italy (2) · Netherlands (2) · United Kingdom (2) · China (1) · France (1) · Iran (1) · Japan (1) · Russia (1)
Paul Orchard, MD (3) · Patricia I Dickson, MD (2) · Agnes Chen, MD (1) · Ali Rabani, Professor (1) · Patricia I Dickson, M.D. (1) · Paul Orchard, M.D. (1) · Shigetoyo Oguri (1) · Tippi MacKenzie, MD (1)
PMID 15324318, PMID 19117887, PMID 19948615, PMID 21637107, PMID 23510062, PMID 25864295, PMID 28119821, PMID 28374935, PMID 28657663, PMID 30337566, PMID 31575939, PMID 32102934, PMID 33874971, PMID 37955580, PMID 39891377, PMID 40830667, PMID 41163043, PMID 9918480
U54NS065768 (1)