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New treatment option for Primary Immune Thrombocytopenia (ITP)
Official title An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT07233213
What this study is testing
What is Human immunoglobulin (pH4) for intravenous injection?
Human immunoglobulin (pH4) for intravenous injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for primary immune thrombocytopenia (itp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- It is a clinical trial of a medicinal product Human Immunoglobulin for Intravenous Injection (5%) manufactured by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as 5% IVIG).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- At the time of signing the informed consent form, male or female patients aged ≥ 18 years and ≤ 65 years;
- Patients with clinically confirmed chronic ITP (i.e., the course of disease \> 12 months from diagnosis to signing the informed consent form);
- Patients who did not use glucocorticoids for at least 2 weeks before the first dose or used a maintenance dose of glucocorticoids for at least 2...
- Platelet count \< 30 × 109/L;
- Patients who understand the procedures and methods of this study, are willing to sign the informed consent form and complete the study in strict...
You likely can't join if
- Patients who are known or suspected to be allergic to human immunoglobulin or other plasma proteins and/or blood products, as well as excipients of...
- BMI ≥ 30 kg/m2;
- Secondary thrombocytopenia;
- Patients with the following clinical manifestations or disease history at screening:
- Hemoglobin \<90 g/L or combined with immune hemolytic anemia;
- Chronic or recurrent neutropenia (defined as absolute neutrophil count \< 1.5 × 109/L);
See the full eligibility criteria
- At the time of signing the informed consent form, male or female patients aged ≥ 18 years and ≤ 65 years;
- Patients with clinically confirmed chronic ITP (i.e., the course of disease \> 12 months from diagnosis to signing the informed consent form);
- Patients who did not use glucocorticoids for at least 2 weeks before the first dose or used a maintenance dose of glucocorticoids for at least 2 weeks before the first dose, and did not plan to increase the dosage of...
- Platelet count \< 30 × 109/L;
- Patients who understand the procedures and methods of this study, are willing to sign the informed consent form and complete the study in strict accordance with the clinical study protocol.
- Patients who are known or suspected to be allergic to human immunoglobulin or other plasma proteins and/or blood products, as well as excipients of the investigational drug, including those with a history of steroid...
- BMI ≥ 30 kg/m2;
- Secondary thrombocytopenia;
- Patients with the following clinical manifestations or disease history at screening:
- Hemoglobin \<90 g/L or combined with immune hemolytic anemia;
- Chronic or recurrent neutropenia (defined as absolute neutrophil count \< 1.5 × 109/L);
- Patients with abnormal liver function: defined as ALT and/or AST \> 3 times of the upper limit of normal; and/or total bilirubin ≥ 1.5 times of the upper limit of normal;
- Patients with related diseases of renal impairment, or serum creatinine ≥ 1.5 times the upper limit of normal value or creatinine clearance \ 160 mmHg or DBP\>100 mmHg) or hypotension (SBP\<90 mmHg or DBP\<60 mmHg); ⑨...
- Patients who failed to respond to previous treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin;
- Patients who had received treatment with human immunoglobulin for intravenous injection or anti-D human immunoglobulin within 4 weeks prior to the first dose, or any other treatment with blood, blood products or blood...
- Patients who have received recombinant human thrombopoietin or eltrombopag and other receptor agonists within 2 weeks prior to the first dose (except for those who are ineffective after stable treatment \> 2 weeks), or...
- Patients who have received immunosuppressive or other immunomodulatory drugs within 3 weeks prior to the first dose (except for the following cases: glucocorticoids with stable dose and no dose change for \> 2 weeks...
- Patients who received rituximab within 8 weeks prior to the first dose;
- Patients who have been vaccinated with live attenuated vaccines within 8 weeks prior to the first dose or are planned to be vaccinated during the trial treatment, such as poliomyelitis vaccine, measles vaccine, rubella...
- Patients scheduled for surgery during the trial and requiring transfusion of blood or blood products;
- Those who planned to continue taking non-steroidal anti-inflammatory drugs, warfarin and other drugs that affect platelet aggregation or coagulation function due to medical history during the trial;
- Patients who tested positive for any of HBs antigen (or nucleic acid test), HCV antibody (or nucleic acid test), Treponema pallidum antibody and HIV antibody (or nucleic acid test) at screening;
- Acute bacterial or acute viral infections that still require antibiotic treatment after enrollment;
- Pregnant and lactating women who have aborted for less than 30 days before signing the informed consent form (currently breastfeeding or currently not artificially breastfeeding but less than one year after delivery)...
- Patients with a history of drug abuse or drug addiction;
- Patients who have participated (already included) in clinical trials of other drugs or medical devices within 3 months before signing the informed consent form;
- The survival time is expected to be less than 3 months, or the patients with other concomitant diseases are severely ill and may be dying during the treatment period and follow-up period. In the investigator's opinion...
- Patients with poor compliance or who are not suitable to participate in this trial for other reasons as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Ankara, Altındağ, Turkey (Türkiye)
- Malatya, Battalgazi, Turkey (Türkiye)
- Istanbul, Fatih, Turkey (Türkiye)
- Kayseri, Melikgazi, Turkey (Türkiye)
- Mersin, Mezitli, Turkey (Türkiye)
- Antalya, Muratpaşa, Turkey (Türkiye)
- Ankara, Yenimahalle, Turkey (Türkiye)
- Adana, Yüreğir, Turkey (Türkiye)
- Gaziantep, Şehitkamil, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ankara, Altındağ, Turkey (Türkiye); Malatya, Battalgazi, Turkey (Türkiye); Istanbul, Fatih, Turkey (Türkiye); Kayseri, Melikgazi, Turkey (Türkiye); Mersin, Mezitli, Turkey (Türkiye); Antalya, Muratpaşa, Turkey (Türkiye) and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.