15 completed, 3 active not recruiting, 3 terminated, 2 recruiting. 18 Phase 2, 8 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 18 | Completed 11, Terminated 3, Recruiting 2, Active not recruiting 1, Withdrawn 1 |
| Phase 3 | 8 | Completed 4, Active not recruiting 2, Terminated 1, Unknown 1 |
| Phase 1 | 1 | Unknown 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 |
|---|---|---|---|---|---|---|
| Open Label Extension to Assess Long Term Safety and Efficacy of KL1333 in Patients With Primary Mitochondrial Disease Napazimone - Mitochondrial Diseases | Phase 2 | Recruiting | Pharming Technologies B.V. | 140 | 2026-06-12 | 2026-09-16 |
| Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation Leniolisib - PIDs Linked to PI3K | Phase 2 | Active not recruiting | Pharming Technologies B.V. | 12 | 2025-04-29 | 2026-09-16 |
| Leniolisib for Immune Dysregulation in CVID Leniolisib - Common Variable Immunodeficiency (CVID) | Phase 2 | Completed | Pharming Technologies B.V. | 27 | 2025-02-12 | 2026-09-18 |
| Leniolisib for Immune Dysregulation in PIDs Leniolisib - Primary Immunodeficiency Disorders (PIDs) | Phase 2 | Completed | Pharming Technologies B.V. | 13 | 2024-10-21 | 2026-10-19 |
| Pediatric Patients Aged 1 to 6 Years With APDS Leniolisib - APDS | Phase 3 | Active not recruiting | Pharming Technologies B.V. | 16 | 2023-08-30 | 2026-06-15 |
| An Open-Label Study to Assess the Safety & Efficacy of Leniolisib in Japanese Patients With APDS Leniolisib - APDS Gene Mutation | Phase 3 | Unknown | Pharming Technologies B.V. | 3 | 2023-08-03 | 2024-02-08 |
| Pediatric Patients Aged 4 to 11 Years With APDS Leniolisib - APDS | Phase 3 | Active not recruiting | Pharming Technologies B.V. | 15 | 2023-02-01 | 2026-05-06 |
| Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease KL1333, Placebo - Primary Mitochondrial Disease | Phase 2 | Recruiting | Pharming Technologies B.V. | 180 | 2022-12-13 | 2026-06-26 |
| Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation Conestat alfa (Ruconest®), NaCl 0.9%) - Acute Ischemic Stroke, Acute Renal Injury | Phase 2 | Completed | University Hospital, Basel, Switzerland | 141 | 2022-03-16 | 2026-04-22 |
| Prevention of Acute Kidney Injury in Patients With NSTEMI conestat alfa or placebo - Non-ST Elevation Myocardial Infarction (NSTEMI) | Phase 2 | Terminated | Pharming Technologies B.V. | 29 | 2021-04-21 | 2024-04-03 |
| Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19 Ruconest - Confirmed Coronavirus Disease | Phase 2 | Completed | Pharming Technologies B.V. | 38 | 2020-11-30 | 2024-02-16 |
| Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19 Conestat alfa - Coronavirus Infections | Phase 2 | Terminated | University Hospital, Basel, Switzerland | 80 | 2020-08-06 | 2021-11-09 |
| RUCONEST® as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function rhC1INH, Saline Solution - Kidney Failure | Phase 1 | Unknown | University of Wisconsin, Madison | 20 | 2019-06-21 | 2020-12-14 |
| Patient Registry to Evaluate the Real-world Safety of Ruconest® rhC1INH - Hereditary Angioedema | Completed | Pharming Technologies B.V. | 152 | 2018-06-30 | 2024-04-05 | |
| Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects Conestat alfa, Sodium chloride 0.9% - Acute Kidney Injury | Phase 2 | Completed | University Hospital, Basel, Switzerland | 80 | 2017-01-01 | 2018-08-08 |
| Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLI CDZ173 - Activated PI3Kdelta Syndrome (APDS); PASLI Disease | Phase 2 / Phase 3 | Terminated | Pharming Technologies B.V. | 37 | 2016-09-08 | 2026-03-30 |
| A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor Recombinant human C1 inhibitor, Placebo - Hereditary Angioedema | Phase 2 | Completed | Pharming Technologies B.V. | 32 | 2014-12-01 | 2017-12-08 |
| Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients rhC1INH - Hereditary Angioedema | Phase 2 | Completed | Pharming Technologies B.V. | 57 | 2012-01-17 | 2024-03-29 |
| C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks rhC1INH or pdC1INH - Hereditary Angioedema | Completed | Pharming Technologies B.V. | 181 | 2011-07-01 | 2025-04-08 | |
| Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks rhC1INH, Placebo (Saline) - Hereditary Angioedema | Phase 3 | Completed | Pharming Technologies B.V. | 75 | 2011-01-01 | 2015-08-07 |
Showing 20 of 26. Sign in to see all of them.
Angioedemas, Hereditary (9) · Angioedema (5) · Genetic Diseases, Inborn (4) · Acute Kidney Injury (2) · Activated PI3K-delta Syndrome (1) · Aortic Valve Stenosis (1) · COVID-19 (1) · Common Variable Immunodeficiency (1) · Coronavirus Infections (1) · Cytokine Release Syndrome (1) · Delayed Graft Function (1) · Diabetes Mellitus (1) · Heart Valve Diseases (1) · Immunologic Deficiency Syndromes (1) · Inflammation (1)
conestat alfa (14) · leniolisib (7) · Sodium Chloride (6) · Complement C1 Inhibitor Protein (4) · Immunoglobulins, Intravenous (1) · Plasmapheresis (1) · Saline Solution (1)
United States (15) · Netherlands (8) · Italy (7) · Czechia (6) · Germany (5) · Romania (5) · Spain (5) · France (4) · North Macedonia (4) · Switzerland (4) · United Kingdom (4) · Hungary (3) · Japan (3) · Poland (3) · Belgium (2)
Anurag Relan, MD (5) · Jan Nuijens, MD, PhD (3) · Amel Karaa, MD (1) · Bruno Giannetti, MD (1) · Gulbu Uzel, M.D. (1) · Hans Sollinger, MD, PhD (1) · Hirokazu Kanegane, Prof. (1) · Jonathan Bernstein, MD (1) · Luis Fernandez (1) · Michael Osthoff, M.D. (1) · Michael Osthoff, PD Dr. med. (1) · Michael Osthoff, Prof. Dr. med. (1) · Raban Jeger, Prof. Dr. med. (1)
PMID 42159953, PMID 20920772, PMID 28284978, PMID 22909164, PMID 23535096, PMID 28754491, PMID 30993784, PMID 32171721, PMID 33397449, PMID 36326435, PMID 37797893, PMID 37965347, PMID 38593221, PMID 41608120
2016 (1), 2025 (1)