Status:
UNKNOWN
Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd.
Conditions:
Primary Immunodeficiency Disease
Eligibility:
All Genders
6-60 years
Phase:
PHASE3
Brief Summary
To evaluate the safety, efficacy, and pharmacokinetic properties of Shu Yang intravenous immune globulin in patients with primary immune deficiency aged less than 60 years. The main benefit of IVIG i...
Detailed Description
This is a Phase III, open-label, prospective, single-arm, multicenter trial to evaluate the efficacy of IVIG in maintaining the average of severe bacterial infections in less than one per year. The sa...
Eligibility Criteria
Inclusion
- Written informed consent/assent.
- Male or female.
- Ages ≤ 60 years old and ≥ 06 years old.
- Diagnosis of Primary Immunodeficiency Disease (PID) with a reduction in antibody production due to:
- a. Common Variable Immunodeficiency (CVID) as per European Immunodeficiency Society (ESID)/Pan American Immunodeficiency Group (PAGID), as defined in section 5.1, OR b. X-linked agammaglobulinemia (XLA) as per ESID/PAGID, as defined in section 5.1.
- Receiving replacement therapy with intravenous immunoglobulin at 21- to 28-day intervals at 300-600 mg/kg/month for a minimum of 2 months before the start of the study;
- Absence of episodes of serious bacterial infections with previous use of an IV immunoglobulin for at least 3 months before screening;
- Negative pregnancy test (in female patients with childbearing potential); readiness to use reliable methods of contraception throughout the study period;
- Patients who participated in a clinical trial with another experimental IVIG may be enrolled if they have a potential benefit according to Res. CNS 251/1997;
- Patients currently on treatment with any subcutaneous or intramuscular immunoglobulin may be enrolled switching to IVIG therapy at the investigator's discretion, considering the potential benefit to the patient.
Exclusion
- Known intolerance or hypersensitivity to immunoglobulins or components of the test article;
- Any contraindications to the use of immunoglobulins;
- Secondary immunodeficiency or conditions potentially causing secondary immunodeficiency such as chronic lymphoid leukemia, lymphoma, multiple myeloma, protein-losing enteropathies or nephropathies, and hypoalbuminemia;
- Clinically relevant changes in the safety exams are defined as:
- Blood count
- o Hb \< 10.5 g/dL
- o Leukocytes \< 3,000 /uL or \>10,000 cells / uL
- o Absolute neutrophil count \< 1,000 cells/mm3;
- Coagulation o TP and aPTT \> 2.5 x ULN
- Biochemistry o glycated hemoglobin \> 6.5%
- total bilirubin and fractions, alkaline phosphatase, ALT, AST, GGT \> 2.5 x ULN
- creatinine above 3mg/dl or creatinine clearance \< 30mL/min
- Urine I.
- Leukocyturia \> 10,000 cells/mL 5. Any cancer either active or resolved within the last 12 months before screening;
- 6\. Receiving any blood products (except intravenous immunoglobulins) during the last 3 months before screening;
- 7\. Any febrile illness within 14 days before enrollment; Note: The patient may be rescreened after recovery.
- 8\. History of thrombotic events (including myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis) within 6 months before enrollment;
- 9\. Previous use of live attenuated virus vaccines;
- 10\. Selective deficiency of immunoglobulin A (IgA) or known antibodies to IgA;
- 11\. Known drug or alcohol abuse;
- 12\. The need to use other investigational drugs, systemic immunosuppressants, and any other immunoglobulins;
- 13\. Pregnancy or lactation;
- 14\. Inability to comply with the protocol activities;
- 15\. PIDs other than CVID or X-linked agammaglobulinemia
- 16\. Patients infected with HIV, HBV or HCV
- 17\. Patients with AIDS, cystic fibrosis, or active hepatitis B or C.
- 18\. Any other condition that, in the Investigator's opinion may increase the risk of participation in this study.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 8 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06089122
Start Date
April 1 2024
End Date
June 8 2025
Last Update
March 12 2024
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