Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
Multicenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC "GENERIUM", Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Idiopathic Thrombocytopenic Purpura
It is a phase III multicenter randomized double-blinded comparative study of clinical efficacy and safety of GNR-069 and Nplate in patients with idiopathic thrombocytopenic purpura
The drug GNR-069(JSC "GENERIUM", Russia) is biosimilar to the original drug Nplate. This study is aimed to compare the clinical efficacy and safety of the drug GNR-069 and the drug Nplate to register of the drug GNR-069 in the Russian Federation for therapy in patients with idiopathic thrombocytopenic purpura (ITP). The study also provides for the evaluation of pharmacokinetic parameters and immunogenicity. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00451594 -
High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP
|
Phase 3 | |
| Withdrawn |
NCT01276561 -
Single Incision Versus Standard Laparoscopic Splenectomy
|
N/A | |
| Completed |
NCT01713855 -
Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura
|
N/A | |
| Recruiting |
NCT03465020 -
Investigation on a Dynamic Cohort of Italian Patients With Active ITP
|
||
| Completed |
NCT00603642 -
P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
|
Phase 3 | |
| Completed |
NCT01143038 -
Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
|
Phase 2 | |
| Not yet recruiting |
NCT04128358 -
Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?
|
N/A | |
| Completed |
NCT00128882 -
Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D
|
Phase 2 | |
| Completed |
NCT01525836 -
rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP
|
Phase 3 | |
| Completed |
NCT00888901 -
Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag
|
Phase 4 | |
| Completed |
NCT00828750 -
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
|
Phase 3 | |
| Completed |
NCT00475423 -
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
|
Phase 2 | |
| Completed |
NCT00625443 -
Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003
|
Phase 2 | |
| Completed |
NCT00454857 -
Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
|
N/A | |
| Completed |
NCT00102323 -
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
|
Phase 3 | |
| Enrolling by invitation |
NCT05492409 -
Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients
|
Phase 3 | |
| Terminated |
NCT01433978 -
A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)
|
Phase 3 | |
| Withdrawn |
NCT01443351 -
Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)
|
||
| Completed |
NCT01520909 -
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
|
Phase 3 | |
| Not yet recruiting |
NCT06287567 -
Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP)
|
Phase 4 |