Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
AstraZeneca
Medtronic
Dow
Merck

Last Updated: June 26, 2022

CLINICAL TRIALS PROFILE FOR PROMACTA KIT


✉ Email this page to a colleague

« Back to Dashboard

All Clinical Trials for Promacta Kit

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00643929 ↗ LENS - Long-term Eltrombopag Observational Study Completed GlaxoSmithKline 2007-02-01 A long term observational ocular safety study in adults who have received study medication (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag. The study will follow subjects for 2.5 years following their last ocular assessment on their prior treatment study (regardless of the therapeutic indication) and will describe long-term ocular safety with respect to changes in the lenses over time from all subjects.
NCT00909363 ↗ Thrombocytopenia and Bleeding in Wiskott-Aldrich Syndrome (WAS) Patients Terminated Novartis Pharmaceuticals Phase 2 2009-06-01 The purpose of this project is to describe the pathophysiology of thrombocytopenia and bleeding in patients with Wiskott-Aldrich Syndrome (WAS) and determine the response to thrombopoietic agents in vitro and in vivo.
NCT00909363 ↗ Thrombocytopenia and Bleeding in Wiskott-Aldrich Syndrome (WAS) Patients Terminated Weill Medical College of Cornell University Phase 2 2009-06-01 The purpose of this project is to describe the pathophysiology of thrombocytopenia and bleeding in patients with Wiskott-Aldrich Syndrome (WAS) and determine the response to thrombopoietic agents in vitro and in vivo.
NCT00922883 ↗ A Pilot Study of the Thrombopoietin-Receptor Agonist Eltrombopag in Refractory Aplastic Anemia Patients Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2009-05-29 Severe aplastic anemia (SAA) is a life-threatening blood disease which can be effectively treated with immunosuppressive drug regimens or allogeneic stem cell transplantation. However, 20-40% of patients without transplant options do not respond to immunosuppressive therapies, and have persistent severe cytopenias, requiring regular platelet transfusions, which are expensive and inconvenient, and are a risk for further serious bleeding complications. Thrombopoietin (TPO) is the principal endogenous regulator of platelet production and also stimulates hematopoietic stem and progenitor cells. A small molecule oral TPO-agonist, eltrombopag has been shown to increase platelets in healthy subjects and in patients with immune thrombocytopenic purpura (ITP), and received FDA approval in 2008 for the treatment of thrombocytopenia in ITP. This Phase 2, non-randomized pilot study of eltrombopag in aplastic anemia patients with immunosuppressive therapy refractory thrombocytopenia will test the safety and potential efficacy of eltrombopag treatment patients with refractory thrombocytopenia following immunosuppression for aplastic anemia. Subjects will initiate study medication at an oral dose of 50 mg/day, which will be increased up to 150 mg/day as clinically indicated to the lowest dose that maintains a stable platelet count 20,000/(micro)L above baseline while maximizing tolerability. Response will be assessed at 3-4 months. Platelet response is defined as platelet count increases to 20,000/L above baseline at three months. or stable platelet counts with transfusion independence for a minimum of 8 weeks. Erythroid response for subjects with a pretreatment hemoglobin of less than 9 g/dL will be defined as an increase in hemoglobin by greater than or equal to 1.5g/dL without packed red blood cell (PRBC) transfusion support, or a reduction in the units of transfusions by an absolute number of at least 4 PRBC transfusions for eight consecutive weeks compared with the pretreatment transfusion number in the previous 8 weeks. Neutrophil response will be defined in those with a pretreatment absolute neutrophil count (ANC) of less than 0.5 times 10(9)/L as at least a 100 percent increase or an absolute increase greater than 0.5 times 10(9)/L. Subjects with response at 3-4 months may continue study medication (extended access) until they meet an off study criteria. The primary objective is to assess the safety and efficacy of the oral thrombopoietin receptor agonist (TPO-R agonist) eltrombopag in aplastic anemia patients with immunosuppressive-therapy refractory thrombocytopenia. Secondary objectives include the analysis of the incidence and severity of bleeding episodes, and the impact on quality of life.
NCT00961064 ↗ A Pilot Study of a Thrombopoietin-Receptor Agonist, Eltrombopag, in Patients With Low to Int-2 Risk Myelodysplastic Syndrome (MDS) Active, not recruiting National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2009-07-24 Background: - Myelodysplastic syndromes (MDS) are bone marrow disorders characterized by anemia, neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet counts). Patients with MDS are at risk for symptomatic anemia, infection, and bleeding, as well as a risk of progression to acute leukemia. Standard treatments for MDS have significant relapse rates. MDS patients with thrombocytopenia who fail standard therapies require regular, expensive, and inconvenient platelet transfusions, and are at risk for further serious bleeding complications. - Eltrombopag is a drug designed to mimic the protein thrombopoietin, which causes the body to make more platelets. Eltrombopag has been able to increase platelet counts in healthy volunteers and in patients with chronic ITP (a disease where patients destroy their own platelets very rapidly and thus develop thrombocytopenia), but researchers do not know if the drug can increase platelet counts in patients with MDS. Objectives: - To find out whether eltrombopag can improve platelet counts in patients with MDS. - To determine whether eltrombopag is safe for patients with MDS. Eligibility: - Patients 18 years of age and older who have consistently low blood platelet counts related to MDS that has not responded to conventional treatment. - Platelet count ≤ 30,000/μL or platelet-transfusion-dependence (requiring at least 4 platelet transfusions in the 8 weeks prior to study entry); OR hemoglobin less than 9.0 gr/dL or red cell transfusion-dependence (requiring at least 4 units of PRBCs in the eight weeks prior to study entry) OR ANC≤500 Design: - Treatment with eltrombopag tablets once per day for 16-20 weeks. - Participants will be monitored closely throughout the initial treatment, with weekly blood tests and separate evaluations at the National Institutes of Health (NIH) treatment center every 4 weeks. Bone marrow biopsies may be conducted to check for abnormalities in bone marrow. - If patients show signs of improved platelet counts after 90 days, treatment will continue with additional doses of eltrombopag. - Patients who discontinue taking eltrombopag will be evaluated at the NIH treatment center 4 weeks after ending treatment, and again 6 months after ending treatment to check for potential side effects.
NCT00996216 ↗ Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390 Completed GlaxoSmithKline Phase 3 2009-09-01 The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.
NCT01000051 ↗ Eltrombopag for Post Transplant Thrombocytopenia Completed Novartis Pharmaceuticals Phase 2 2010-02-17 The goal of this clinical research study is to learn if eltrombopag can help to improve platelet counts in patients with low platelets after they have had a stem cell transplant. The safety of this drug will also be studied.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Promacta Kit

Condition Name

Condition Name for Promacta Kit
Intervention Trials
Thrombocytopenia 9
Leukemia 4
Hepatitis C 3
Adult Acute Myeloblastic Leukemia With Maturation (M2) 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Promacta Kit
Intervention Trials
Thrombocytopenia 16
Leukemia 8
Myelodysplastic Syndromes 6
Preleukemia 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Promacta Kit

Trials by Country

Trials by Country for Promacta Kit
Location Trials
United States 52
Italy 13
Canada 10
Germany 10
Brazil 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Promacta Kit
Location Trials
Texas 7
New York 6
Maryland 5
California 4
North Carolina 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Promacta Kit

Clinical Trial Phase

Clinical Trial Phase for Promacta Kit
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2/Phase 3 2
[disabled in preview] 21
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Promacta Kit
Clinical Trial Phase Trials
Completed 11
Terminated 8
Active, not recruiting 6
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Promacta Kit

Sponsor Name

Sponsor Name for Promacta Kit
Sponsor Trials
GlaxoSmithKline 15
M.D. Anderson Cancer Center 6
Novartis Pharmaceuticals 5
[disabled in preview] 16
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Promacta Kit
Sponsor Trials
Other 29
Industry 26
NIH 9
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
McKinsey
Dow
Express Scripts
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.