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Safety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises In Hospitalized Subjects With Sickle Cell Disease

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
University of South Alabama Women's and Children's Hospital
Mobile, Alabama, 36604 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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years of age. Male and female subjects of childbearing potential and at risk for pregnancy
must agree to use a highly effective method of contraception throughout the study.
Diagnosis of VOC necessitating IV opioids and admission to the hospital. Able to receive
the first dose of rivipansel within 24 hours from administration of the first dose of IV
opioids for this hospitalization.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

(B5201002). Occurrence of any severe and/or generalized cutaneous manifestation or any
other adverse event during participation in Study B5201002 that was related to study drug
and which would therefore make it inappropriate for the subject to receive rivipansel in
the current study. Other severe acute or chronic medical or psychiatric condition or
laboratory abnormality that may increase the risk associated with study participation or
study drug administration or may interfere with the interpretation of study results.
Clinically significant deterioration in renal function in Study B5201002. Pregnant female
subjects, breastfeeding female subjects and male and female subjects of childbearing
potential who are unwilling or unable to use a highly effective method of contraception.
Active use of illicit drugs and/or alcohol dependence.

NCT02433158
Pfizer
Recruiting
Safety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises In Hospitalized Subjects With Sickle Cell Disease

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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