Is NCT07059000 recruiting in Greenville, NC?

Yes, NCT07059000 is currently recruiting participants at its Greenville, NC location. This immune thrombocytopenia clinical trial is actively enrolling qualified participants.

How do I join the immune thrombocytopenia clinical trial in Greenville?

To join this clinical trial in Greenville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Greenville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Immune Thrombocytopenia Clinical Trial in Greenville, NC

Who Can Participate

Inclusion Criteria

Male or female, 18-70 years of age.

Patient has signed the ICF.

Diagnosis of chronic (\> 12 months duration) ITP as defined by the International Working Group.

Mean screening platelet count of \< 30 × 10\^9/L from two qualifying counts measured at least one calendar day apart. The first qualifying count can be from historical data if measured within 7 days prior to screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.

A pre-infusion platelet count of \< 30 × 10\^9/L at the Baseline Visit.

Patient is willing to comply with all requirements of the protocol.

Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and agree to employ adequate birth control measures during the study.

Authorization to access personal health information.

Exclusion Criteria

Patients incapable of giving informed consent.

Patients with secondary ITP (all forms of immune-mediated thrombocytopenia except primary ITP). e.g., lupus erythematosus, rheumatoid arthritis, drug-related ITP, and Human Immunodeficiency Virus (HIV).

Patients with Evans Syndrome.

Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.

History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.

Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients.

Patient unresponsive previously to IVIg or anti-D Ig treatment.

Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.

Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period.

Participants with known inherited thrombocytopenia. e.g., MYH-9 disorders.

Participants with myelodysplastic syndrome (MDS).

Administration of IVIg, anti-D immunoglobulin, Mercaptopurine, Vinca alkaloid, or platelet enhancing drugs (including thrombopoietin receptor agonists \[TPO-RA\], immunosuppressive, or other immunomodulatory drugs) within 3 weeks of the Baseline Visit, except for:

patients on a stable dose of TPO-RA within 4 weeks of the Baseline Visit

patients on a stable dose of Mycophenolate Mofetil within 3 months of the Baseline Visit

patients on stable dose of Danazol within 3 months of the Baseline Visit

long-term corticosteroid therapy for ITP, when the dose had been stable within 3 weeks of the Baseline Visit and no dosage change was planned until the EOS Visit

long-term azathioprine, cyclophosphamide, or attenuated androgen therapy when the dose had been stable within 3 months of the Baseline Visit, and no dosage change was planned until after study completion. Treatment with any other products licensed for primary chronic ITP is also exclusive. An appropriate wash-out period must be determined in case of patients who might be eligible for treatment with IVIg.

Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit.

Received rituximab within 6 months of the Baseline Visit.

Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1).

Received recombinant activated factor VII within 7 days of the Baseline Visit.

Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit.

Use of loop diuretics within 1 week of the Baseline Visit.

Patients at high risk of thrombotic events.

Uncontrolled hypertension \[i.e., diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>160 mmHg\]. If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.

Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity.

Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.

Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia.

Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis):

alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5x \> upper limit of normal (ULN)

creatinine \> 120 μmol/L

blood urea nitrogen (BUN) \> 2.5x ULN

Signs of severe anemia: Hemoglobin of less than 7 g/dL, hemodynamically unstable due to active bleeding, and/or when evidence of end-organ ischemia secondary to severe anemia is present.

Body mass index \> 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload.

History of a malignant disease within 3 years of the Baseline Visit other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin.

Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit or within 5 half-lives of the investigational medicinal product (IMP) under investigation.

Any condition that the Investigator believes is likely to interfere with evaluation of the IMP or with satisfactory conduct of the trial.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Greenville?

Yes, this clinical trial (NCT07059000) has an active research site in Greenville, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Immune Thrombocytopenia Treatment Options in Greenville, NC

If you're searching for immune thrombocytopenia treatment options in Greenville, NC, this clinical trial (NCT07059000) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Greenville research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced immune thrombocytopenia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all immune thrombocytopenia clinical trials near you to find additional studies recruiting in your area.

Immune Thrombocytopenia Clinical Trial in Greenville, NC

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