Bleeding Clinical Trial
— WASOfficial title:
Effects Of Eltrombopag On Thrombocytopenia, Platelet Function and Bleeding In Patients With Wiskott-Aldrich Syndrome/X-Linked Thrombocytopenia.
NCT number | NCT00909363 |
Other study ID # | 0801009600 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2009 |
Est. completion date | June 30, 2017 |
Verified date | March 2019 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 24 |
Est. completion date | June 30, 2017 |
Est. primary completion date | May 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 3 Months to 80 Years |
Eligibility |
Inclusion Criteria: In order to be eligible for study entry, subjects must comply with the following: - Males from 3 months old to 80 years old - Signed written informed consent obtained prior to study entry - Clinical diagnosis of WAS or XLT - Platelet levels less than 100 x 109/L - Adequate renal and hepatic function (creatinine and bilirubin less than or equal to 1.5 x IULN, AST and ALT less than or equal to 2.5 x IULN) Exclusion Criteria: Any patient is ineligible for study entry if he/she: - Over the age of 80 - Women (only males are eligible) - fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study or until at least 6 months after treatment - Aspirin, aspirin-containing compounds, salicylates, non-steroidal anti-inflammatory medications (NSAIDS), clopidogrel or ticlopidine, warfarin or other vitamin K antagonists, unfractionated or low molecular heparin within 7 days of first infusion - Red blood cell transfusion in the past four weeks - Elevated (> 1.5 x ULN) prothrombin time (PT) or partial thromboplastin time (PTT) - New York Heart Classification III or IV heart disease. Other severe cardiovascular or cardiopulmonary disease, including COPD. - Known HIV infection, hepatitis B or C infection - Any infection requiring antibiotic treatment within 3 days - Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations. - Prior malignancy with less than a 5-year disease-free interval, excluding nonmelanoma skin cancers and carcinoma in situ of the cervix |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | How Many WAS Patients Will Achieve Platelet Counts Above 50,000/ul. | number of WAS patients achieving this increase to > 50,000/uL without rescue medication in the previous 3 weeks during eltrombopag treatment | 12 weeks | |
Secondary | Number of Patients With Wiskott-Aldrich Syndrome (WAS) With Grade 3 or Higher Bleeding or SAE (on WHO Scale) | number of patients with bleeding SAEs while on treatment and/or number of patients with grade 3 or higher bleeding on WHO (World Health Organization) scale: the scale is from 1 to 5 with 5 = fatality and 1=very little bleeding | 12 Weeks | |
Secondary | How Many Patients With WAS Had Abnormal Platelet Function Including Activation | in how many patients with WAS were platelets dysfunctional or activated before treatment as measured by flow cytometry to a substantial degree and the same after treatment with eltrombopag | 12 weeks | |
Secondary | How Many Patients With WAS Had Substantially Increased Platelet Production After Eltrombopag | in how many patients with WAS did eltrombopag increase platelet production as measured by the immature platelet fraction (IPF), a variable derived from the Sysmex auto analyzer, which is considered to be a measure of newly formed platelets ie reticulated platelets | 12 weeks |
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