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Clinical Trials/NCT01320865
NCT01320865
Withdrawn
Not Applicable

Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib

The Cleveland Clinic1 site in 1 countryAugust 2010
ConditionsPAH

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PAH
Sponsor
The Cleveland Clinic
Locations
1
Primary Endpoint
Measuring circulating markers of Nilotinib affect
Status
Withdrawn
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
December 2012
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kewal Asosingh, Ph.D

Associate Staff

The Cleveland Clinic

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Evaluate effect of Nilotinib on the activation of mast cells.(within one year of the end of the study)

Study Sites (1)

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