16 completed, 5 terminated, 4 withdrawn, 1 unknown. 13 Phase 3, 12 Phase 2, 2 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 6, Terminated 3, Withdrawn 3, Unknown 1 |
| Phase 2 | 12 | Completed 9, Withdrawn 2, Terminated 1 |
| Phase 1 | 2 | Completed 1, Terminated 1 |
| Phase 4 | 1 | Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Liprotamase, porcine PERT - Exocrine Pancreatic Insufficiency, Cystic Fibrosis | Phase 3 | Unknown | Anthera Pharmaceuticals | 140 | 2017-04-28 | 2018-03-08 |
| EASY: Extended Access to Sollpura Over Years Liprotamase - Exocrine Pancreatic Insufficiency, Cystic Fibrosis | Phase 4 | Completed | Anthera Pharmaceuticals | 25 | 2016-09-01 | 2018-05-17 |
| SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis Liprotamase Powder for Oral Solution - Exocrine Pancreatic Insufficiency, Cystic Fibrosis | Phase 3 | Completed | Anthera Pharmaceuticals | 15 | 2016-06-01 | 2018-05-11 |
| CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis Blisibimod, Placebo - Systemic Lupus Erythematosus | Phase 3 | Terminated | Anthera Pharmaceuticals | 3 | 2016-06-01 | 2017-05-23 |
| MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP Blisibimod, Placebo - Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura | Phase 2 / Phase 3 | Withdrawn | Anthera Pharmaceuticals | 2015-12-01 | 2015-07-30 | |
| CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis Blisibimod, Placebo - Systemic Lupus Erythematosus | Phase 3 | Withdrawn | Anthera Pharmaceuticals | 2015-12-01 | 2015-08-13 | |
| SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis Liprotamase, porcine (pig) PERT - Exocrine Pancreatic Insufficiency, Cystic Fibrosis | Phase 3 | Completed | Anthera Pharmaceuticals | 128 | 2015-06-01 | 2018-08-14 |
| BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis Blisibimod, Placebo - Granulomatosis With Polyangiitis, Microscopic Polyangiitis | Phase 2 | Withdrawn | Anthera Pharmaceuticals | 2014-12-01 | 2015-07-30 | |
| BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy Blisibimod, Placebo - IgA Nephropathy | Phase 3 | Withdrawn | Anthera Pharmaceuticals | 2014-10-01 | 2015-07-30 | |
| BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration Blisibimod, Placebo - IgA Nephropathy | Phase 2 / Phase 3 | Completed | Anthera Pharmaceuticals | 57 | 2013-06-01 | 2017-09-18 |
| CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus blisibimod, Placebo - Systemic Lupus Erythematosus | Phase 3 | Completed | Anthera Pharmaceuticals | 442 | 2013-02-01 | 2017-02-03 |
| A Study of Varespladib Infusion in Subjects With Sickle Cell Disease. Varespladib, Placebo (Normal Saline) - Sickle Cell Disease, Vaso-occlusive Crisis | Phase 2 | Terminated | Anthera Pharmaceuticals | 2 | 2012-02-01 | 2014-03-04 |
| Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects varespladib methyl - Healthy Volunteers | Phase 1 | Completed | Anthera Pharmaceuticals | 6 | 2011-06-01 | 2011-12-20 |
| A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function varespladib methyl - Renal Impairment | Phase 1 | Terminated | Anthera Pharmaceuticals | 28 | 2011-06-01 | 2012-03-20 |
| A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 A-623 - Systemic Lupus Erythematosus | Phase 2 | Completed | Anthera Pharmaceuticals | 382 | 2011-04-01 | 2014-02-13 |
| PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus A-623, Placebo Comparator - Systemic Lupus Erythematosus | Phase 2 | Completed | Anthera Pharmaceuticals | 547 | 2010-07-01 | 2014-03-04 |
| VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome A-002, varespladib methyl, Placebo - Acute Coronary Syndrome | Phase 3 | Terminated | Anthera Pharmaceuticals | 5189 | 2010-05-01 | 2012-10-31 |
| FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes Varespladib Methyl (A-002) - Acute Coronary Syndrome | Phase 2 | Completed | Anthera Pharmaceuticals | 625 | 2008-07-01 | 2014-03-04 |
| Phase III ALTU-135 CP Safety Trial Liprotamase - Exocrine Pancreatic Insufficiency | Phase 3 | Terminated | Anthera Pharmaceuticals | 39 | 2007-12-01 | 2014-10-24 |
| sPLA2 Inhibition to Decrease Enzyme Release After PCI Trial Varespladib (A-002), placebo - Coronary Artery Disease | Phase 2 | Completed | University Health Network, Toronto | 164 | 2007-10-01 | 2009-10-09 |
Showing 20 of 26. Sign in to see all of them.
Exocrine Pancreatic Insufficiency (8) · Cystic Fibrosis (7) · Autoimmune Diseases (5) · Lupus Erythematosus, Systemic (5) · Coronary Artery Disease (3) · Acute Coronary Syndrome (2) · Anemia, Sickle Cell (2) · Glomerulonephritis, IGA (2) · Nephritis (2) · Vaso-Occlusive Crises (2) · Acute Chest Syndrome (1) · Angina, Unstable (1) · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (1) · Atherosclerosis (1) · Granulomatosis with Polyangiitis (1)
AMG623 peptibody (9) · liprotamase lipase (8) · varespladib methyl (7) · varespladib (3) · Atorvastatin (1) · Saline Solution (1) · Solutions (1)
United States (17) · Czechia (4) · Georgia (4) · Hong Kong (4) · Hungary (4) · India (4) · Philippines (4) · Poland (4) · Spain (4) · Taiwan (4) · Brazil (3) · Canada (3) · Colombia (3) · Israel (3) · Mexico (3)
Monica Gangal (2) · Vladimir Dzavik, MD (1)
PMID 33687069, PMID 32761612, PMID 19231633, PMID 20863951, PMID 21081550, PMID 21098449, PMID 24247616, PMID 24748629, PMID 26032537, PMID 29563108