IV Gammaglobulin for Sickle Cell Pain Crises

Phase 1 & 2

Recruiting

Led By Deepa G Manwani, M.D

Research Sponsored by Deepa Manwani

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented diagnosis of sickle cell disease (SS or S-β thalassemia genotype)

Uncomplicated acute pain episode requiring hospital admission and parenteral narcotics

Must not have

Prior thromboses or current estrogen use

Concomitant acute process, including fever > 38.5° C with clinical suspicion of infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from admission to discharge, average 4 days and maximum 30 days

Summary

This trial will test if a drug called immune globulin is safe and effective for treating pain in people with sickle cell disease.

Who is the study for?

This trial is for individuals aged 12-65 with sickle cell disease experiencing a pain crisis needing hospital care. It's open to those not on chronic transfusion or at high stroke risk, without recent live vaccines, illicit drug abuse history, certain blood levels (Hb >10 g/dL or <5 g/dL), pregnancy, thrombosis risks like estrogen use, suspected infections, kidney issues, other drug trials participation, IgA deficiency or gamma globulin allergies.

What is being tested?

The study tests if intravenous immune globulin can safely and effectively treat acute pain crises in sickle cell disease compared to normal saline. Participants are hospitalized and receive either the immune therapy or a saline solution as part of the treatment process.

What are the potential side effects?

Possible side effects include allergic reactions to the infusion ingredients such as headache, nausea, vomiting; potential organ inflammation; increased infection risk; and possible impact on liver enzymes which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with sickle cell disease.

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I was hospitalized for severe pain that needed strong painkillers given through an IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had blood clots before or am currently using estrogen.

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I currently have a fever over 101.3°F possibly due to an infection.

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I have kidney issues indicated by high creatinine or protein in my urine.

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I am currently receiving regular blood transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from admission to discharge, average 4 days and maximum 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from admission to discharge, average 4 days and maximum 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from admission to discharge, average 4 days and maximum 30 days for reporting.