Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib
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ClinicalTrials.gov Identifier: NCT01320865 |
Recruitment Status
:
Withdrawn
First Posted
: March 23, 2011
Last Update Posted
: February 4, 2014
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Tracking Information | ||||
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First Submitted Date | March 18, 2011 | |||
First Posted Date | March 23, 2011 | |||
Last Update Posted Date | February 4, 2014 | |||
Study Start Date | August 2010 | |||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Measuring circulating markers of Nilotinib affect [ Time Frame: within one year of the end of the study ] We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib.
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Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01320865 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
Evaluate effect of Nilotinib on the activation of mast cells. [ Time Frame: within one year of the end of the study ] We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib. We will also look at the proliferation of mast cell progenitors and correlate this to clinical markers used to monitor this disease.
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Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib | |||
Official Title | Not Provided | |||
Brief Summary | The investigators hypothesize that bone marrow progenitor cells are mobilized into the circulation in PAH, home to the lungs and differentiate into mast cells, which promote vascular remodeling and vasoconstriction through release of renin and chymase. As a corollary to this, the investigators hypothesize that anti cKit tyrosine kinase inhibitor (TKI), nilotinib, provides clinical benefit to patients through inhibition of mast cell progenitor proliferation, mobilization and differentiation. To test this, the investigators will determine if mast cell progenitors and mast cell biomarkers are related to nilotinib clinical response. This will be an ancillary study, part of a placebo-controlled, double-blind multi center clinical trial of nilotinib in pulmonary arterial hypertension. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Patients diagnosed with PAH that are enrolled in the Nilotinib clinical trial. http://clinicaltrials.gov/ct2/show/NCT01179737?term=tasigna+and+pulmonary+hypertension&rank=1 | |||
Condition | PAH | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Subjects with PAH treated with nilotinib | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Withdrawn | |||
Actual Enrollment |
0 | |||
Original Estimated Enrollment |
66 | |||
Actual Study Completion Date | December 2012 | |||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria: This study is a substudy and subjects must be enrolled in the main trial: See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737) http://clinicaltrials.gov/ct2/show/NCT01179737? Exclusion Criteria: Subjects are not enrolled in the main study: See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737) http://clinicaltrials.gov/ct2/show/NCT01179737?term=tasigna+and+pulmonary+hypertension&rank=1 |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01320865 | |||
Other Study ID Numbers | Novartis AMN-107 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Kewal Asosingh, Ph.D, The Cleveland Clinic | |||
Study Sponsor | The Cleveland Clinic | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | The Cleveland Clinic | |||
Verification Date | February 2014 |