14 completed, 2 recruiting, 1 active not recruiting, 1 enrolling by invitation. 9 Phase 3, 4 Phase 1, 4 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 7, Active not recruiting 1, Recruiting 1 |
| Phase 1 | 4 | Completed 4 |
| Phase 2 | 4 | Completed 4 |
| Phase 4 | 1 | Recruiting 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 |
|---|---|---|---|---|---|---|
| TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends treprostinil - Pulmonary Arterial Hypertension (PAH) | Not yet recruiting | AOP Orphan Pharmaceuticals AG | 300 | 2026-07-01 | 2026-07-30 | |
| Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH preservative-free parenteral treprostinil - Pulmonary Arterial Hypertension | Phase 3 | Recruiting | AOP Orphan Pharmaceuticals AG | 20 | 2024-07-31 | 2025-05-31 |
| A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients Pulmonary Arterial Hypertension | Enrolling by invitation | AOP Orphan Pharmaceuticals AG | 110 | 2024-07-31 | 2024-08-07 | |
| Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients Generic treprostinil sodium + Standard of Care (Double Oral), Standard of Care - Double Oral - Pulmonary Arterial Hypertension | Phase 4 | Recruiting | AOP Orphan Pharmaceuticals AG | 110 | 2023-12-06 | 2024-03-19 |
| A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients Ropeginterferon alfa-2b (BESREMi®) - Essential Thrombocythaemia | Phase 3 | Active not recruiting | AOP Orphan Pharmaceuticals AG | 117 | 2023-12-04 | 2024-12-19 |
| ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission AOP2014 / Pegylated-Proline-interferon alpha-2b, Surveillance - Chronic Myeloid Leukemia in Remission | Phase 3 | Completed | Philipps University Marburg | 214 | 2017-05-04 | 2023-03-31 |
| The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV AOP2014, Phlebotomies, ASA - Polycythemia Vera | Phase 2 | Completed | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS | 127 | 2017-02-02 | 2024-09-19 |
| Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients Pegylated-Proline-Interferon alpha-2b in a Pre-filled Pen - Polycythemia Vera | Phase 3 | Completed | AOP Orphan Pharmaceuticals AG | 30 | 2015-07-01 | 2016-02-17 |
| AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study. Pegylated-Proline-interferon alpha-2b, Best available therapy (BAT) - Polycythemia Vera | Phase 3 | Completed | AOP Orphan Pharmaceuticals AG | 170 | 2014-11-01 | 2021-06-01 |
| Anagrelide Retard in Essential Thrombocythemia Anagrelide retard, Thromboreductin - Essential Thrombocythemia | Phase 3 | Completed | AOP Orphan Pharmaceuticals AG | 106 | 2014-02-01 | 2015-07-29 |
| Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera Peg-P-IFN-alpha-2b (AOP2014), Hydroxyurea - Polycythemia Vera | Phase 3 | Completed | AOP Orphan Pharmaceuticals AG | 257 | 2013-09-01 | 2016-11-28 |
| Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response P1101 - Chronic Phase Chronic Myeloid Leukemia | Phase 1 | Completed | Arbeitsgemeinschaft medikamentoese Tumortherapie | 12 | 2013-08-30 | 2019-01-04 |
| Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers LDLL600, Brevibloc - Healthy | Phase 1 | Completed | AOP Orphan Pharmaceuticals AG | 14 | 2012-12-01 | 2015-04-21 |
| A Pharmacokinetic, Pharmacodynamic, Safety Study With AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers LDLA202, ONO LDL50, Esmolol hydrochloride - Healthy | Phase 1 | Completed | AOP Orphan Pharmaceuticals AG | 12 | 2012-07-01 | 2012-09-05 |
| A Short Term Pharmacokinetic, Pharmacodynamic and Tolerability Study to Compare AOP200704 vs. Esmolol AOP200704, Esmolol hydrochloride, infusion - Healthy Volunteers, Pharmacokinetics/Dynamics Study | Phase 2 | Completed | AOP Orphan Pharmaceuticals AG | 16 | 2011-03-01 | 2012-07-19 |
| Anagrelide Retard vs. Placebo: Efficacy and Safety in "At-risk" Patients With Essential Thrombocythaemia Anagrelide retard, Placebo - Essential Thrombocythaemia | Phase 3 | Completed | AOP Orphan Pharmaceuticals AG | 146 | 2010-12-01 | 2016-05-26 |
| Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera PEG-P-INF alpha-2b (P1101) - Polycythemia Vera | Phase 1 / Phase 2 | Completed | AOP Orphan Pharmaceuticals AG | 24 | 2010-08-01 | 2018-01-30 |
| Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis Moli1901, Moli1901 placebo - Cystic Fibrosis | Phase 2 | Completed | AOP Orphan Pharmaceuticals AG | 160 | 2007-10-01 | 2009-08-27 |
| Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia Anagrelide, Hydroxyurea - Essential Thrombocythaemia | Phase 3 | Completed | AOP Orphan Pharmaceuticals AG | 2002-09-01 | 2010-10-06 |
Polycythemia Vera (5) · Pulmonary Arterial Hypertension (4) · Thrombocythemia, Essential (4) · Myeloproliferative Disorders (3) · Bone Marrow Diseases (2) · Hematologic Diseases (2) · Polycythemia (2) · Cystic Fibrosis (1) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (1) · Leukemia, Myeloid, Chronic-Phase (1) · Thrombocytosis (1)
esmolol (3) · Hydroxyurea (2) · anagrelide (2) · peginterferon alfa-2b (2) · Aspirin (1) · Blood Specimen Collection (1) · Moli1901 (1) · Standard of Care (1) · duramycin (1) · treprostinil (1)
Austria (13) · Czechia (10) · France (9) · Poland (9) · Hungary (8) · Germany (7) · Italy (6) · Romania (6) · Spain (6) · Bulgaria (5) · Slovakia (5) · Russia (4) · Ukraine (4) · Lithuania (3) · Belgium (1)
Heinz Gisslinger, MD (3) · Barbara Grohmann-Izay, MD (2) · Andreas Burchert, Prof. Dr. (1) · Ernst Eber, Prof Dr (1) · Franck E Nicoloni, MD, PhD (1) · Heinz Gisslinger, Prof., MD (1) · Ivan Ulc, Dr. med. (1) · Ivan Ulc, MD (1) · Josef Thaler, MD (1) · Tiziano Barbui, Professor (1)
PMID 23315161, PMID 26261238, PMID 28091703, PMID 30287855, PMID 32678292, PMID 32888826, PMID 33476571, PMID 38320126
2014 (2), 2023 (2), 2016 (1)