New IVIG treatment aims to boost platelets in bleeding disorder
NCT ID NCT06962631
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether V-IMMUNE, a human immunoglobulin given through a vein, can safely raise platelet counts in people with immune thrombocytopenia (ITP). About 31 adults and children aged 1 year and older with very low platelets will receive two daily infusions. The main goal is to see if platelets reach a safe level within 9 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- V-IMMUNE (human immunoglobulin given intravenously)
- What this could lead to
- If successful, this could provide a safe and effective treatment option to quickly raise platelet counts and reduce bleeding risk in people with immune thrombocytopenia.
- What could go wrong
- This is a small, single-group study comparing results to historical data, not a placebo-controlled trial. The treatment may not work for everyone and carries risks like infusion reactions or blood clots.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 31 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥1 year; * Confirmed diagnosis of immune thrombocytopenia ( newly diagnosed, persistent or chronic); * Platelet count ≤20,000/mm³ at the time of enrollment; * No other conditions that, in the investigator's opinion, could cause thrombocytopenia; * Agreement to use effective contraceptive practices/methods throughout the entire study participation by female patients of childbearing potential and able to become pregnant, unless there is a documented medical contraindication. Exclusion Criteria: * Non-immune thrombocytopenia * Active sepsis * Pregnancy (pregnant or breastfeeding) * History of hypersensitivity reaction to blood or blood products, IVIG, or any other IgG preparation * Intolerance to any component of V-IMMUNE® * Previous diagnosis of IgA deficiency, history of reactions to products containing IgA, or history of anti-IgA antibodies * Participation in any other study involving an investigational product * Known HIV, HCV, or HBV infection * AST (TGO) and/or ALT (TGP) \>2.5× the upper limit of normal or 2.5 times baseline values * Serum creatinine \>2× the upper limit of normal or 2 times baseline values * BUN \>2.5× the upper limit of normal or 2.5 times baseline values * History of NYHA class III or IV heart failure * Uncontrolled hypertension with systolic BP \>180 mmHg or diastolic BP \>100 mmHg * A history of hyperviscosity states, transient ischemic attack (TIA), stroke, other thromboembolic events, or acute coronary syndrome (ACS) * Neoplasia under active treatment * Child-Pugh class B or C liver failure * Alcohol, opioid, or psychotropic substance abuse within the past 12 months * Receipt of rituximab within 6 months prior to Day 1 * Acute or chronic conditions (e.g., but not limited to, renal disease or diseases predisposing to renal impairment, coronary artery disease, or protein-losing enteropathy) that, in the investigator's opinion, may interfere with the conduct of the study An acquired health condition such as chronic lymphocytic leukemia, multiple myeloma, or chronic or recurrent neutropenia (absolute neutrophil count \<1,000/mm³) History of hemolytic anemia Receipt of any IV immunoglobin preparation within 1 month prior to Day 1 Use of corticosteroids, cyclophosphamide, azathioprine, or attenuated androgens with a planned dose increase before Day 10 following IV immunoglobin infusion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IMIP Instituto de Medicina Integral Professor Fernando Figueira
NOT_YET_RECRUITINGRecife, Pernambuco, 50070-902, Brazil
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Santa Casa de Misericórida de São Paulo
RECRUITINGSão Paulo, São Paulo, 01221020, Brazil
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Other studies related to the condition(s) this trial covers.
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- Can a bispecific antibody tame two autoimmune blood disorders?
- Can a gut bacteria transplant help when steroids fail for a bleeding disorder?
- Will a new drug form work the same? study tests two versions of SKI-O-703
- New drug mimics IVIg to fight low platelet disorder