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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 November 15, 2019

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Study Location
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242 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.
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- 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
Completed
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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Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anemia, Sickle Cell
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Rivipansel Treatment Arm
    Intervention: Drug: Rivipansel
  • Placebo Comparator: Placebo Treatment Arm
    Intervention: Other: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2019)
345
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2014)
350
Actual Study Completion Date  ICMJE June 27, 2019
Actual Primary Completion DateMay 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02187003
Other Study ID Numbers  ICMJE B5201002
RESET ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

ICMJE     Data element required by the

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

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