Human normal immunoglobulin (IV) for Chronic immune thrombocytopenia (ITP)

Inclusion criteria

• {"criterion_text":"- 1.\tMale or female, 18-70 years of age.\n- 2.\tPatient and/or legal authorized representative has signed the ICF.\n- 3.\tDiagnosis of chronic (> 12 months duration) ITP as defined by the International Working Group.\n- 4.\tMean screening platelet count of < 30 × 109/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 the screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.\n- 5.\tPlatelet count of < 30 × 109/L at the Baseline Visit.\n- 6.\tPatient is willing to comply with all requirements of the protocol.\n- 7.\tWomen of childbearing potential must have a negative urine pregnancy test at screening and agree to employ adequate birth control measures during the study.\n- 8.\tAuthorization to access personal health information."}

Exclusion criteria

• {"criterion_text":"- 1. Patients with secondary ITP\n- 18. Signs of severe anemia\n- 19. BMI > 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload\n- 2. Patients with Evans Syndrome, inherited thrombocytopenia, myelodysplastic syndrome\n- 20. History of a malignant disease within 3 years of the Baseline Visit other than treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin\n- 21. Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit\n- 3. Patients infected with HBV, HCV or HIV\n- 4. Patients with a history of thrombotic events and/or at high risk of thrombotic events\n- 5. History of hypersensitivity to IVIg or to any of the excipients\n- 6. Patients unresponsive previously to IVIg or anti-D Ig treatment\n- 7. Patients with immunoglobulin A deficiency and Ab against IgA\n- 10. Received platelets within 7days of Visit 1 and any other blood/plasma product within 1 month of the Baseline Visit (BV)\n- 8. Splenectomy within 4 weeks of the Baseline Visit or planned throughout the study\n- 9. Administration of IVIg, anti-D Ig, Mercaptopurine, Vinca alkaloid, or platelet enhancing drugs within 3 weeks of the Baseline Visit unless patients are on stable treatment as defined. Treatment with any other products licensed for primary chronic ITP is also exclusive.\n- 11. Received recombinant activated factor VII within 7 days rituximab within 6 months of the BV\n- 12 Received live attenuated virus vaccines within 3 months of the BV\n- 13. Use of loop diuretics w/i 1 week of the BV\n- 14. Uncontrolled hypertension\n- 15. Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events , unstable or advanced ischemic heart disease, hyperviscosity\n- 16. Patients with significant protein losing enteropathy, nephrotic syndrome, lymphangiectasia, hyperproteinemia, increased serum viscosity and/or hyponatremia\n- 17. Severe liver or kidney disease"}

Primary endpoints

• {"endpoint_text":"- The rate of participants with response (R), defined as participants with a platelet count > 30 × 109/L and at least a 2-fold increase of the baseline count, confirmed during the evaluation period on at least 2 separate occasions at least 7 days apart, and absence of bleeding during the evaluation period.","definition_or_measurement_approach":"Responder (R) defined as platelet count > 30 × 109/L and ≥2-fold increase from baseline, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding during the evaluation period."}

Secondary endpoints

• {"endpoint_text":"- 1.Number and rate of participants with: a.CR: PLT > 100x109/L on 2 occasions at least 7 days apart and no bleeding b. loss of CR or R: PLT <100x109/L or bleeding ( CR) or PLT <30x109/L or < 2-fold increase of baseline or bleeding (R) c.Nonresponders (NR)","definition_or_measurement_approach":"Classification into Complete Response (CR), loss of CR or R, and Nonresponders using platelet thresholds and bleeding absence/presence as specified (CR: PLT >100x10^9/L on 2 occasions ≥7 days apart and no bleeding; loss definitions per text)."}
• {"endpoint_text":"- 2.Time to response","definition_or_measurement_approach":"Time from baseline to first qualifying platelet response as defined in primary/secondary endpoint definitions."}
• {"endpoint_text":"- 3. Response Duration","definition_or_measurement_approach":"Duration from first confirmed response until loss of response per protocol definitions."}
• {"endpoint_text":"- 4. Hemorrhages regression of","definition_or_measurement_approach":"Assessment of bleeding regression (timing/grade as per study assessments)."}
• {"endpoint_text":"- 5. maximum PLT count achieved","definition_or_measurement_approach":"Maximum platelet count recorded during the evaluation period."}
• {"endpoint_text":"- 6.Time to maximum PLT count","definition_or_measurement_approach":"Time from baseline to attainment of maximum platelet count."}
• {"endpoint_text":"- 7.Bleedings (timing/grade)","definition_or_measurement_approach":"Assessment and grading of bleedings by timing and grade according to protocol-specified bleeding assessment."}

Methods

• Facebook Ad — digital/social media advertising (files present for IT, RO, CZ, DE, ES)
• Print Ad — printed advertisement materials (files present for IT, RO, CZ, DE, ES)
• Video Script — video recruitment content (files present for IT, RO, CZ, DE, ES)
• Advocacy Outreach Text — outreach messages targeting patient advocacy/interest groups (country-specific files present)
• HCP letter — healthcare professional letters to inform/referral (country-specific files present)
• Patient letter — direct patient invitation letters (country-specific files present)

Czechia

Earliest CTIS Part Ii Submission Date

27-03-2025

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

403

Number Of Sites

2

Number Of Participants

2

Germany

Earliest CTIS Part Ii Submission Date

17-04-2025

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

378

Number Of Sites

1

Number Of Participants

3

Italy

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

399

Number Of Sites

5

Number Of Participants

6

Romania

Earliest CTIS Part Ii Submission Date

27-03-2025

Latest Decision Or Authorization Date

05-05-2026

Processing Time Days

404

Number Of Sites

3

Number Of Participants

5

Spain

Earliest CTIS Part Ii Submission Date

23-01-2025

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

466

Number Of Sites

3

Number Of Participants

8

Primary sponsor

Full Name

Kedrion S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties codes: 1,12,13,15 (samples storage),2,3,4,5,8,9 (as listed in CTIS third-party duties)

Third parties

• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient recruitment","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"samples storage (other duties indicated by codes present in record)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}