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Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease

Last updated on March 25, 2018

FOR MORE INFORMATION
Study Location
University of South Alabama Children's and Women'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
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.
Show details

- At least 6 years of age.

- Documented diagnosis of sickle cell disease.

- Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with
treatment including IV opioids.

- Able to receive the first dose of study drug within 24 hours from the administration
of IV opioids.

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

- Serious systemic infection

- Acute Chest Syndrome

- Serious concomitant medical problems (for example, stroke)

- SCD pain atypical of VOC

- Severe renal or hepatic impairment

- Chronic pain rather than a presentation of acute VOC

NCT02187003
Pfizer
Recruiting
Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease

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Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy And Safety Of Rivipansel (Gmi-1070) In The Treatment Of Vaso-occlusive Crisis In Hospitalized Subjects With Sickle Cell Disease
This is a clinical study evaluating the efficacy and safety of rivipansel (GMI-1070) in treating subjects with sickle cell disease (SCD) who are 6 years of age or older experiencing a pain crisis necessitating hospitalization.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anemia, Sickle Cell
  • Drug: Rivipansel
    Rivipansel (GMI-1070) will be infused intravenously every 12 hours up to 15 doses maximum. Subjects aged 12 and over who weigh more than 40 kilograms will receive a dose of 1680 mg of rivipansel, followed by a dose of 840 mg of rivipansel every 12 hours. All subjects aged 6 to 11 years and any subject who weighs 40 kilograms or less, will receive weight-based dosing (mg/kg) of 40 mg/kg of rivipansel (maximum of 1680 mg) followed by a dose of 20 mg/kg of rivipansel (maximum of 840 mg) every 12 hours.
    Other Name: GMI-1070
  • Other: Placebo
    Placebo (phosphate buffered saline) will be infused intravenously every 12 hours up to 15 doses maximum.
    Other Name: phosphate buffered saline
  • Experimental: Rivipansel Treatment Arm
    Intervention: Drug: Rivipansel
  • Placebo Comparator: Placebo Treatment Arm
    Intervention: Other: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
July 10, 2018
July 10, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 6 years of age.
  • Documented diagnosis of sickle cell disease.
  • Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with treatment including IV opioids.
  • Able to receive the first dose of study drug within 24 hours from the administration of IV opioids.

Exclusion Criteria:

  • Serious systemic infection
  • Acute Chest Syndrome
  • Serious concomitant medical problems (for example, stroke)
  • SCD pain atypical of VOC
  • Severe renal or hepatic impairment
  • Chronic pain rather than a presentation of acute VOC
Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Canada,   United States
 
 
NCT02187003
B5201002
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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