CompletedPhase 3

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

United States, Canada345 participantsStarted 2015-06-17

Plain-language summary

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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Readiness for Discharge From Hospital

Timeframe: Day 1 up to the latest day when all 6 criteria of readiness-for-discharge were met (up to an average of Day 8)

Trial details

NCT IDNCT02187003

SponsorBiossil Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-03

Results submitted2024-02-26

View on ClinicalTrials.gov More Anemia, Sickle Cell trials

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.