CTRI/2022/12/048138尚未招募3 期
A Prospective, Nonrandomized, Open label, Single Arm, Multicentric, Phase III Clinical Study To Evaluate Efficacy, Pharmacokinetics And Safety of Human Normal Immunoglobulin For Intravenous Administration In Patients With Primary Immunodeficiency Diseases
Intas Pharmaceutical Ltd India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply-
- •1 Participant or their legally acceptable representative must sign ICF indicating that he or she understands the purpose of, procedures and restriction required for the study Parent(s) (preferably both if available or as per local requirements) must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study.2 Participant must be 2 to 65 years of age (both inclusive) at the time of providing the informed
- •consent.3 Participants with documented clinical diagnosis of a primary immunodeficiency disease as
- •defined by IUIS (International Union of Immunological Societies) and require treatment with IVIg. Confirmation of PID diagnosis may include a review of infection history, serum IgG
- •concentration at diagnosis and prior to immunoglobulin therapy and responses (failure to
- •achieve two fold rise in IgG antibody titre) to vaccination with polysaccharide and protein
- •vaccines.4 Participants with documented agammaglobulinemia (defined as the total absence of one or more classes of antibodies) or hypogammaglobulinemia (defined as low levels of one or more classes [that is at least 2 standard deviations under the mean level per age) including but not limited to the following: humoral-based immunodeficiency syndromes (e.g., X-linked
- •agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (e.g., hyper-immunoglobulin M [IgM] immunodeficiency syndrome)
- •Newly diagnosed participants- who are eligible to receive IVIg treatment as per the investigator discretion.• Participants already on IVIg treatment- Participants must be receiving IVIg treatment for primary immunodeficiency
- •- Participant must be receiving stable dose of an approved IVIg within 200-900 mg/kg (± 20% of the mean dose for the last 3 infusions) with established treatment intervals of 21- or 28-day (±3 days or ±4 days, respectively) for at least 3 infusion cycles (one of which could be the screening visit result).- At least 2 documented IgG trough levels while receiving an IVIg, of more than or equal to 450 mg/dL obtained at 2 infusion cycles within 12 months (1 must be within 6months) prior to enrollment.5 Participants who are otherwise medically stable on the basis of physical examination, medical history and vital signs, chest x-ray and 12-lead ECG performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator.6 Participants who are otherwise medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically
- •significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant source documents and initialed by the investigator.7 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:• Is not
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:1 History of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, psychiatric, or metabolic disturbances. 2 Known allergies, hypersensitivity, or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following human normal immunoglobulin intravenous or its excipients or following plasma-derived products (refer to the prescribing information
- •of study intervention) OR known history of anaphylactic reactions to IgA found in other
- •products.3 Exposure to blood or any blood product or derivative, other than commercially available
- •human IVIg or human albumin within the past 3 months.4 Participant has known Selective Immunoglobulin A (IgA) Deficiency (with or without
- •antibodies to IgA). (Note: exclusion is for the specific diagnostic entity. It does not exclude
- •other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring immune globulin [IgG] replacement).
- •5 Participant with an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (ANC less than 1000 cells/mm3), or human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome (AIDS).6 Participant having contraindication for intravenous immunoglobulin or has been diagnosed
- •with dysgammaglobulinemia, isolated IgG subclass deficiency, isolated specific antibody
- •deficiency disorder, or transien hypogammaglobulinemia of infancy.7 History of autoimmune hemolytic anemia.8 History of congenital impairment of pulmonary function.
- •9 The participant currently has a known hyperviscosity syndrome.10 Participant has a predisposition for acute renal failure (e.g. any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs) and/or has a history of acute renal failure; and/or is on dialysis.11 Participant has total protein >9 g/dL and/or participants with myeloma, macroglobulinemia (IgM) and paraproteinemia.
- •12 Participant (if less than 18 years of age) has non-controlled hypertension at a level of greater than or equal to the 90th percentile blood pressure (either systolic or diastolic) for their age and height or the adult participant has non-controlled arterial hypertension (systolic blood pressure more than or equal to 160 mmHg and/or diastolic blood pressure more than or equal to 100 mmHg).13 Participant has a known history, or is positive at enrollment, for human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus.14 Participant with documented history of bleeding disorders or who are on anti-coagulation therapy.15 Participant has an active viral or bacterial infection or symptoms/signs consistent with such
- •an infection (as documented by culture or diagnostic imaging and (or) a body temperature
- •exceeding 38.5°C (101.3°F)), excluding chronic sinusitis or bronchiectasis, within the two
- •weeks prior to the initial dose of investigational product. Participants may be receiving antibiotics as long as signs/symptoms of infection have been absent for two weeks prior to the initial infusion of IP.Note: If an viral or bacterial infection occurs during the screening peri
研究者
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