A Phase Ib Study of NVX-508 in Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT03013426|
Recruitment Status : Withdrawn (NuvOx Pharma suspended the clinical program related to this study.)
First Posted : January 6, 2017
Last Update Posted : July 16, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Drug: NVX-508||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib, Dose-finding and Pharmacodynamic Study of NVX-508 in Sickle Cell Disease Patients|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Administration of 1, 2 or 4 doses of NVX-508 at three dose levels; 0.05ml/kg. 0.1ml/kg and 0.17ml/kg in a 3 + 3 design.
Administration of NVX-508 emulsion intravenously
- Maximum tolerated dose of NVX-508 [ Time Frame: 1 year ]
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Clinical diagnosis of SCD without acute VOE and/or ACS.
- Age 18 years and older
Adequate hematologic, renal and hepatic function, defined by:
- Absolute neutrophil count (ANC) ≥ 1.5 x109/L
- Platelet count ≥ 100 x 109/L,
- Hemoglobin ≥ 60 g/L
- International normalized ratio (INR) < 1.5 x upper limit of normal (ULN)
- Activated partial thromboplastin time (APTT) < 1.5 x ULN
- Plasma creatinine < 1.5 x ULN
- Total bilirubin < 2.5 x ULN (in the presence of Gilbert's syndrome or indirect hyperbilirubinemia caused by hemolysis)
- Aspartate transaminase (AST) < 2.5 x ULN
- Alanine transaminase (ALT) < 2.5 x ULN
- Ability of the prospective subject to understand and willingness to sign written informed consent document
- Patients who have received any other investigational agent within 4 weeks before enrollment.
- Patients who have had a VOE/ACS in the previous 4 weeks before enrollment.
- Stroke or transient ischemic attack within 6 months before enrollment.
- Myocardial infarction within 6 months before enrollment, unstable angina, New York Heart Association class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 100 mmHg).
- Congenital long QT syndrome, or corrected QT interval ( QTc) > 450 milliseconds (msec) in males and > 470 mSec in females on EKG.
- Uncontrolled arrhythmia or any history of clinically significant arrhythmia in the past 6 months
- Clinically-significant chronic obstructive pulmonary disease or asthma that is not controlled by medication.
- A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
- Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins or low-dose aspirin.
- History of allergic reactions attributed to compounds of similar chemical composition to NVX- 508.
- Women who are pregnant or breastfeeding.
- Inability to comply with study procedures.
- History or evidence of any other clinically-significant condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with study procedures, evaluation or completion.
- Patients with active VOE or ACS or other significant current acute complication of SCD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013426
|Principal Investigator:||Amma T Owusu-Ansah, MD||University of Pittsburgh|
|Responsible Party:||Amma Owusu-Ansah, MD, Assistant Professor of Medicine and Clinical Director, Center for Translational and International Hematology, University of Pittsburgh|
|Other Study ID Numbers:||
|First Posted:||January 6, 2017 Key Record Dates|
|Last Update Posted:||July 16, 2018|
|Last Verified:||July 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn