A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)
NCT01054443 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-03-18
Summary
The primary objective of this study was to assess the efficacy of 3 dose levels of lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
Conditions
- Immune Thrombocytopenia (ITP)
Interventions
- DRUG
-
Tablet
- DRUG
-
Lusutrombopag
Tablet
Sponsors & Collaborators
-
Shionogi
lead INDUSTRY
Principal Investigators
-
Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-03-18
- Primary Completion
- 2010-11-24
- Completion
- 2010-11-24
Countries
- United States
Study Locations
More Related Trials
-
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
NCT00102336 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
NCT04224688 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)
NCT01438840 ·Status: COMPLETED ·Phase: PHASE3
-
SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
NCT00102739 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
NCT06544499 ·Status: RECRUITING ·Phase: PHASE3
-
The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients
NCT03951623 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
NCT04638829 ·Status: COMPLETED ·Phase: PHASE4
-
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
NCT06291415 ·Status: WITHDRAWN ·Phase: PHASE1
-
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
NCT04089267 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
NCT04200456 ·Status: TERMINATED ·Phase: PHASE3
-
Proof-of-Concept: A Pilot, Randomized, Double-Blind Study of Oseltamivir Versus Placebo for Immune Thrombocytopenia
NCT03520049 ·Status: UNKNOWN ·Phase: PHASE3
-
Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP
NCT05369208 ·Status: COMPLETED ·Phase: PHASE3
-
A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)
NCT02203422 ·Status: WITHDRAWN ·Phase: PHASE3
-
Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults
NCT04518475 ·Status: RECRUITING ·Phase: PHASE4
-
Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)
NCT06594146 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety Study of AMG 531 in Japanese Subjects With ITP
NCT00305435 ·Status: COMPLETED ·Phase: PHASE2
-
Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation
NCT00621894 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP
NCT03524612 ·Status: COMPLETED ·Phase: PHASE2
-
Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children
NCT03939637 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia
NCT02227693 ·Status: COMPLETED ·Phase: PHASE2
-
Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP
NCT04917679 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate Belimumab for the Treatment of Chronic Immune Thrombocytopenia.
NCT01440361 ·Status: WITHDRAWN ·Phase: PHASE2
-
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)
NCT01433978 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia
NCT06900920 ·Status: RECRUITING ·Phase: PHASE3
-
A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
NCT01098487 ·Status: COMPLETED ·Phase: PHASE4