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Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Santa Monica, California, 90403 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Severe Thrombocytopenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Men and women must be 18 to 65 years of age, with nonmyeloid malignancies for whom
oprelvekin is indicated.

- At least one documented occasion of adequate hematologic recovery from previous or
current chemotherapy.

- Adequate renal and hepatic excretory function.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- A marked baseline prolongation of QT/QTc interval (eg, repeated [two out of three
readings] demonstration of a QTcF interval >450 msec.

- Additional risk factors for torsades de pointes including heart failure (subjects that
have functional class III or IV congestive heart failure), hypokalemia,
hypomagnesemia, or hypocalcemia.

- A pace maker or defibrillator.

- A history of LQTS, syncope, seizure, or the unexplained cardiac-related death of a
family member at less than 30 years of age.

- Requirement of concomitant prescription or non-prescription medications or dietary
supplements that have a risk of causing torsades de pointes or prolonged QT/QTc
interval.

NCT00886743
Pfizer
Terminated
Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia

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