Home
Clinical Trials
Safety of Rivipansel (GMI-107...

Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-16

Study Completion Date

2019-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02187003

Anemia, Sickle Cell

COMPLETED PHASE3

Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease

NCT00911495

Sickle Cell Disease

COMPLETED PHASE1/PHASE2

Study of GMI-1070 for the Treatment of Sickle Cell Pain Crisis

NCT01119833

Sickle Cell Disease Vaso-occlusive Crisis Pain Crisis

COMPLETED PHASE2

A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease

NCT03132324

Sickle Cell Disease

TERMINATED PHASE1

A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)

NCT03285178

Sickle Cell Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open label extension study in subjects who are 6 years of age or older with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002). This study is designed to evaluate the safety and describe the efficacy of rivipansel as treatment for one or more vaso-occlusive crisis (VOC) events in hospitalized subjects with SCD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sickle Cell Anemia Sickle Cell Disease Sickle Cell Disorders Pain Crisis Vaso-occlusive Crisis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Includes one adult stratum (\>18 years old) and one pediatric stratum (12-17 years old). Subjects aged 12 and over who weigh \>40 kg, will receive a loading dose of 1680 mg followed by a maintenance dose of 840 mg.

Group Type EXPERIMENTAL

Rivipansel

Intervention Type DRUG

Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.

Cohort 2

Includes one pediatric stratum (6-11 years old). Subjects 6 to 11 years of age or subjects who weigh 40 kg, will receive a loading dose of 40 mg/kg (maximum of 1680 mg) followed by a maintenance dose of 20 mg/kg (maximum of 840 mg).

Group Type EXPERIMENTAL

Rivipansel

Intervention Type DRUG

Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rivipansel

Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GMI-1070

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Completion of Study B5201002.
* Documented diagnosis of SCD.
* At least 6 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

* Non-compliance with study procedures in the double blind study (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.

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Alabama Women's and Children's Hospital

Mobile, Alabama, United States

Site Status

Arkansas Children's Hospital Research Pharmacy

Little Rock, Arkansas, United States

Site Status

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

UC Davis Medical Center Main Hospital

Sacramento, California, United States

Site Status

University of California Davis Medical Center

Sacramento, California, United States

Site Status

Howard University Center for Sickle Cell disease

Washington D.C., District of Columbia, United States

Site Status

MedStar Health Research Institute

Washington D.C., District of Columbia, United States

Site Status

Howard University Hospital

Washington D.C., District of Columbia, United States

Site Status

Golisano Childrens Hospital of Southwest Florida

Fort Myers, Florida, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status