24 completed, 4 terminated, 1 unknown. 20 Phase 3, 4 Phase 4, 2 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 20 | Completed 17, Terminated 3 |
| Phase 4 | 4 | Completed 2, Terminated 1, Unknown 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Completed 2 |
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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 |
|---|---|---|---|---|---|---|
| Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery Coagadex - Factor 10 Deficiency | Completed | Bio Products Laboratory | 3 | 2018-02-27 | 2021-11-12 | |
| Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects HRIG, HyperRAB, RabAvert - Healthy | Phase 2 / Phase 3 | Completed | Bio Products Laboratory | 162 | 2017-12-08 | 2020-02-25 |
| Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases Subgam - Primary Immune Deficiency Disorders, Common Variable Immunodeficiency | Phase 3 | Completed | Bio Products Laboratory | 38 | 2015-08-20 | 2018-09-12 |
| A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 Years FACTOR X - Factor X Deficiency | Phase 3 | Completed | Bio Products Laboratory | 9 | 2015-04-01 | 2018-04-02 |
| Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A Optivate 500IU - Haemophilia A | Phase 4 | Terminated | Bio Products Laboratory | 7 | 2014-11-21 | 2021-07-22 |
| Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting Primary Immunodeficiency Disease (PIDD) | Completed | BriovaRx Infusion Services | 20 | 2014-06-01 | 2019-08-07 | |
| Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases Gammaplex (5%), Gammaplex 10 - Primary Immune Deficiency Disorders, Common Variable Immunodeficiency | Phase 3 | Completed | Bio Products Laboratory | 48 | 2014-02-01 | 2017-03-29 |
| An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum Gammaplex 5% - Autism, Autistic Disorder | Phase 4 | Unknown | Isaac Melamed | 30 | 2013-06-01 | 2015-04-16 |
| A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency Gammaplex - Primary Immune Deficiency Disorders, Common Variable Immunodeficiency | Phase 4 | Completed | Bio Products Laboratory | 25 | 2011-03-01 | 2014-12-23 |
| Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery FACTOR X - Factor X Deficiency | Phase 3 | Terminated | Bio Products Laboratory | 4 | 2011-03-01 | 2019-02-05 |
| A Study Investigating Treatment Factor X in People With Factor X Deficiency Human Coagulation FACTOR X - Factor X Deficiency | Phase 3 | Completed | Bio Products Laboratory | 16 | 2010-01-01 | 2014-12-12 |
| A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) Gammaplex, intravenous immunoglobulin - Chronic Idiopathic Thrombocytopenic Purpura | Phase 3 | Completed | Bio Products Laboratory | 35 | 2007-09-01 | 2013-03-01 |
| Optivate in People With Von Willebrand Disease Undergoing Surgery Optivate - Von Willebrand Disease | Phase 3 | Terminated | Bio Products Laboratory | 25 | 2007-02-01 | 2010-03-03 |
| A Study With OPTIVATE® in People With Von Willebrand Disease Optivate - Von Willebrand Disease | Phase 3 | Terminated | Bio Products Laboratory | 26 | 2006-11-01 | 2010-03-03 |
| Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases. Gammaplex (Intravenous immunoglobulin) - Primary Immunodeficiency, Common Variable Hypogammaglobulinemia | Phase 3 | Completed | Bio Products Laboratory | 50 | 2006-01-01 | 2013-01-24 |
| An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery Replenine®-VF (High Purity Factor IX) - Haemophilia B | Phase 3 | Completed | Bio Products Laboratory | 2005-12-01 | 2018-02-22 | |
| A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years Replenine®-VF (High Purity Factor IX) - Haemophilia B | Phase 3 | Completed | Bio Products Laboratory | 2005-08-01 | 2014-10-13 | |
| A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease. Optivate® (Human Coagulation Factor VIII), Haemate P® (Human Coagulation Factor VIII) - vonWillebrand's Disease | Phase 2 | Completed | Bio Products Laboratory | 2004-12-01 | 2018-02-15 | |
| A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers Gammaplex® (Human Normal Immunoglobulin) - Healthy | Phase 1 | Completed | Bio Products Laboratory | 2004-08-01 | 2018-02-27 | |
| A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers. D-Gam® (human anti-D immunoglobulin), Rhophylac® (human anti-D immunoglobulin) - Healthy | Phase 1 | Completed | Bio Products Laboratory | 2004-05-01 | 2018-03-14 |
Showing 20 of 29. Sign in to see all of them.
Primary Immunodeficiency Diseases (6) · Hemophilia A (5) · Hemophilia B (5) · Common Variable Immunodeficiency (4) · Factor X Deficiency (4) · Hyper-IgM Immunodeficiency Syndrome (4) · Bruton type agammaglobulinemia (3) · von Willebrand Diseases (3) · Wiskott-Aldrich Syndrome (2) · Agammaglobulinemia (1) · Asperger Syndrome (1) · Autistic Disorder (1) · Bacterial Infections (1) · Child Development Disorders, Pervasive (1) · Hemostatic Disorders (1)
optivate (8) · gamma-Globulins (6) · Factor VIII (5) · Factor X (4) · Immunoglobulins, Intravenous (2) · Rho(D) Immune Globulin (1) · factor VIII, von Willebrand factor drug combination (1)
United Kingdom (16) · United States (11) · Poland (8) · Israel (4) · Germany (2) · Spain (2) · Turkey (Türkiye) (2) · Argentina (1) · Chile (1) · Colombia (1) · Hungary (1) · India (1) · Romania (1) · Russia (1) · Ukraine (1)
Eric Wolford (3) · Amy Shapiro, Dr (1) · Charles Hay, MD (1) · David Wessels, MBChB MBA (1) · Dr A Sutton, MB BS, FFARCSI (1) · Elizabeth Holmes, MD (1) · Isaac Melamed, MD (1) · Melvin Berger, MD (1) · Ri Liesner, Dr (1) · Thynn Thynn Yee (1) · Tim Aldwinckle (1) · Tim J Aldwinckle, MD (1) · Tim J. Aldwinckle, MD (1)
PMID 36818468, PMID 24892422, PMID 26222441, PMID 29545231, PMID 39271296, PMID 39919133, PMID 41773292