Safety, Pharmacokinetic, and Pharmacodynamic Study of NKTT120 in Adult Patients With Stable Sickle Cell Disease (SCD)

Completed · Phase 1

Conditions studied: Sickle Cell Disease

In brief

The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics of NKTT120 in adult patients with stable sickle cell disease.

Key facts

Study ID

NCT01783691

Run by

NKT Therapeutics

People needed

21

Starts

2013-02-01

Expected to finish

2015-05-01

Last updated by the study team

2015-06-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 50 years
• Subject has a confirmed diagnosis of HbSS or HbSβ0thal
• Subject has stable SCD defined as not having acute VOC, ACS, or other major SCD associated event during the month prior to enrollment

You may not qualify if…

• Subject had an SCD-related VOC or ACS that required hospitalization or treatment in acute care outpatient setting in the month prior to enrollment
• Subject requires a program of prescheduled regularly administered packed red blood cell (pRBC) transfusions or Subject received a pRBC transfusion in the month prior to enrollment
• Subject has evidence of latent or active tuberculosis
• Subject has a major concurrent illness or medical condition
• Subject is pregnant or nursing

Where it is running

• Children's Hospital & Research Center at Oakland — Oakland, California, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• UNC Sickle Cell Program — Chapel Hill, North Carolina, United States
• Blood Center of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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