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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01950585 |
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Date of registration:
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21/09/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Hydroxyurea in Pulmonary Arterial Hypertension
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Scientific title:
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Hydroxyurea in Pulmonary Arterial Hypertension |
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Date of first enrolment:
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September 6, 2013 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT01950585 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Moonjung Jung, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Heart, Lung, and Blood Institute (NHLBI) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
- Age greater than or equal to 18 years old
- Patients with idiopathic or familial PAH with WHO II-III performance status
- On PAH medications that have not changed and are stable for the past two months
- Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody.
EXCLUSION CRITERIA:
- Thrombocytopenia with platelets less than 100,000/mm3, anemia with hemoglobin less
than 10.5g/dL or neutropenia with ANC less than 1500/mm3
- Creatinine > 2.0mg/dL
- Hepatic insufficiency (transaminase levels >4 fold the upper limit of normal or
bilirubin >2 fold the upper limit of normal)
- Severe arterial hypertension (systolic blood pressure >200mmHg or diastolic >120mmHg)
- Female subjects who are nursing or pregnant or are unwilling to take oral
contraceptives or refrain from pregnancy if of childbearing potential
- Participation in any other investigative treatment studies at the time of enrollment
- Unable to understand the investigational nature of the study or give informed consent
(i.e. decisionally impaired)
- Evidence of major bleeding or active infection
- Known allergy to the study drug or drugs similar to the study drug
- Subjects with known liver cirrhosis or chronic active hepatitis.
- HIV positivity
- Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary,
infectious, or metabolic disease of such severity that it would preclude the patient s
ability to tolerate protocol therapy, or that death within 30 days is likely
- Presence of 9;22 BCR/ABL translocation as detected by conventional bone marrow
cytogenetics or PCR for BCR/ABL transcript, or presence of JAK2 V617F mutation in bone
marrow or peripheral blood cells.
- On beta-blocker therapy requiring dose adjustment.
Age minimum:
18 Years
Age maximum:
110 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Intervention(s)
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Drug: Hydroxyurea
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Primary Outcome(s)
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The change in concentration of CD34+ circulating progenitors from baseline to 6 months (24 weeks (+/- 7 days)) on hydroxyurea.
[Time Frame: ongoing]
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Secondary ID(s)
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130203
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13-H-0203
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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