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Immunomodulator

IV Gammaglobulin for Sickle Cell Pain Crises

Q: What ailment does Immune Globulin Intravenous commonly treat?

Immune Globulin Intravenous is typically prescribed to patients with bruton's agammaglobulinemia. It may also aid in mitigating primary immunodeficiencies (PID), agammaglobulinemia, and chronic inflammatory demyelinating polyradiculoneuropathy.

Q: Does this research initiative include individuals aged 55 or older?

The study necessitates that participants are between 12 and 65 years old. There exist 217 trials for younger subjects, and 349 clinical trials designed for those above the age of 65.

Q: Is enrollment in this experiment accessible at present?

According to clinicaltrials.gov, the recruitment of participants into this medical trial is ongoing; it was initially published on November 1st 2008 and last edited on July 25th 2022.

Q: Who qualifies to participate in this medical experiment?

This investigation is accepting 94 candidates suffering from <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, aged between 12 and 65. Furthermore, to be eligible for the trial they must possess a confirmed diagnosis of <a href="https://www.withpower.com/clinical-trials/sickle-cell">sickle cell</a> disease (SS or S-β thalassemia genotype) and experience an uncomplicated acute somatic episode necessitating hospitalisation and intravenous narcotics. For Phase 1 enrolment they should be over twelve years old while in Phase 2 participants must be younger than 14.

Q: How many participants are included in this research endeavor?

Affirmative. According to the data currently housed on clinicaltrials.gov, this research project is in its recruitment phase. It was initially posted on November 1st 2008 and last edited July 25th 2022; with 94 patients being sought after from a single site.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study drug infusion to end of crisis, average 4 days and maximum 30 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with sickle cell disease.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study drug infusion to end of crisis, average 4 days and maximum 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study drug infusion to end of crisis, average 4 days and maximum 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study drug infusion to end of crisis, average 4 days and maximum 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of vaso-occlusive crisis

Secondary outcome measures

In vitro adhesion assays

Time to end of vaso-occlusive crisis

Total opioid use in equivalent of mg of IV morphine

Side effects data

From 2019 Phase 3 trial • 82 Patients • NCT02269163

21%

Sinusitis

20%

Upper respiratory tract infection

17%

Headache

12%

Cough

Haemosiderinuria

Dizziness

Bronchitis

Viral upper respiratory tract infection

Anxiety

Nasopharyngitis

Asthma

Fatigue

Acute sinusitis

Pain

Pyrexia

Arthralgia

Influenza

Ear infection

Nasal congestion

Lymphadenopathy

Procedural headache

Procedural pain

Rhinorrhoea

Migraine

Sinus congestion

Urticaria

Abdominal pain

Knee arthroplasty

Rash

Conjunctivitis

Upper limb fracture

Cervical spinal stenosis

Pulmonary embolism

Nausea

Local swelling

Urinary tract infection

Fall

Paraesthesia

Sinus headache

Oropharyngeal pain

Back pain

Gastroenteritis

Pneumonia

Diarrhoea

Pain in extremity

Gastroenteritis viral

Pharyngitis

Dyspnoea

Epistaxis

100%

80%

60%

40%

20%

Study treatment Arm

CP Treatment Period

Prometic IGIV 10% Treatment Period

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Immune Globulin IntravenousExperimental Treatment1 Intervention

IVIG used in the trial is the GAMUNEX brand, at doses up through 800 mg/kg in Phase 1 and at 400mg/kg in Phase 2.

Group II: Normal salinePlacebo Group1 Intervention

An equivalent volume (weight-based)of normal saline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Immune Globulin Intravenous

2016

Completed Phase 3

~90

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Deepa ManwaniLead Sponsor

Albert Einstein College of MedicineLead Sponsor

287 Previous Clinical Trials

11,856,808 Total Patients Enrolled

Deepa G Manwani, M.DPrincipal InvestigatorAlbert Einstein College of Medicine

Media Library

Immune Globulin Intravenous (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT01757418 — Phase 1 & 2

Sickle Cell Disease Research Study Groups: Immune Globulin Intravenous, Normal saline

Sickle Cell Disease Clinical Trial 2023: Immune Globulin Intravenous Highlights & Side Effects. Trial Name: NCT01757418 — Phase 1 & 2

Immune Globulin Intravenous (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01757418 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailment does Immune Globulin Intravenous commonly treat?

"Immune Globulin Intravenous is typically prescribed to patients with bruton's agammaglobulinemia. It may also aid in mitigating primary immunodeficiencies (PID), agammaglobulinemia, and chronic inflammatory demyelinating polyradiculoneuropathy."

Answered by AI

Does this research initiative include individuals aged 55 or older?

"The study necessitates that participants are between 12 and 65 years old. There exist 217 trials for younger subjects, and 349 clinical trials designed for those above the age of 65."

Answered by AI

Is enrollment in this experiment accessible at present?

"According to clinicaltrials.gov, the recruitment of participants into this medical trial is ongoing; it was initially published on November 1st 2008 and last edited on July 25th 2022."

Answered by AI

Who qualifies to participate in this medical experiment?

"This investigation is accepting 94 candidates suffering from pain, aged between 12 and 65. Furthermore, to be eligible for the trial they must possess a confirmed diagnosis of sickle cell disease (SS or S-β thalassemia genotype) and experience an uncomplicated acute somatic episode necessitating hospitalisation and intravenous narcotics. For Phase 1 enrolment they should be over twelve years old while in Phase 2 participants must be younger than 14."

Answered by AI

How many participants are included in this research endeavor?

"Affirmative. According to the data currently housed on clinicaltrials.gov, this research project is in its recruitment phase. It was initially posted on November 1st 2008 and last edited July 25th 2022; with 94 patients being sought after from a single site."

Answered by AI

Recent research and studies

American Journal of HematologyJournal

Single-dose Intravenous Gammaglobulin Can Stabilize Neutrophil Mac-1 Activation in Sickle Cell Pain Crisis

Manwani, Deepa, Grace Chen, Veronica Carullo, Stelian Serban, Olugbenga Olowokure, Jungeun Jang, Matthew Huggins, et al.. 2015. “Single-dose Intravenous Gammaglobulin Can Stabilize Neutrophil Mac-1 Activation in Sickle Cell Pain Crisis”. American Journal of Hematology. Wiley. doi:10.1002/ajh.23956.

BloodJournal

Intravenous Immunoglobulins Reverse Acute Vaso-occlusive Crises in Sickle Cell Mice Through Rapid Inhibition of Neutrophil Adhesion

Chang, Jungshan, Patricia A. Shi, Elaine Y. Chiang, and Paul S. Frenette. 2008. “Intravenous Immunoglobulins Reverse Acute Vaso-occlusive Crises in Sickle Cell Mice Through Rapid Inhibition of Neutrophil Adhesion”. Blood. American Society of Hematology. doi:10.1182/blood-2007-04-084061.

BloodJournal

Vaso-occlusion in Sickle Cell Disease: Pathophysiology and Novel Targeted Therapies

Manwani, Deepa, and Paul S. Frenette. 2013. “Vaso-occlusion in Sickle Cell Disease: Pathophysiology and Novel Targeted Therapies”. Blood. American Society of Hematology. doi:10.1182/blood-2013-05-498311.

BloodJournal