Health Condition 1: D801- Nonfamilial hypogammaglobulinemia
Conditions
Interventions
Intervention1: ImmunoRel®(Immunoglobulin G- IgG): The recommended dose of ImmunoRel® for patients with PID is 200-800 mg/kg administered every 3/4 weeks as an intravenous infusion
Control Intervention
Sponsors
Dr Mukesh M Desai
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 2 to 65 years 2. Patients with confirmed diagnosis of primary immunodeficiency, predominantly antibody deficient, or common variable immunodeficiency (CVID) with a history of hypogammaglobulinemia (i.e., IgG 3. Treatment naïve patients eligible to receive intravenous immunoglobulin or, patients already on intravenous immunoglobulin infusions every 3 or every 4 weeks for =6 months at a dose aimed to be between 200 and 800 mg/kg with at least two documented IgG trough levels in the previous two infusions before enrolment in the study. 4. The screening laboratory tests must meet the following criteria: a. WBC =3.5 x 109/L b. Neutrophils =1.5 x 109/L c. Platelets =100 x 109/L d. Serum transaminase =2 times the upper limit of normal e. Alkaline phosphatase levels =2 times the upper limit of normal f. Serum creatinine =150 µmol/L (=1.7mg/dL) 5. Patients must be able to adhere to the study visit schedule and other protocol requirements. 6. If subject is a female and is -of child bearing potential, she should be practicing an acceptable method of birth control for the duration of the study as suggested by the investigator, such as a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier method), intrauterine device (IUD), or abstinence OR surgically sterile, bilateral tubal ligation done at least 6 months before the study should be documented 7. Patients/LAR must be capable of giving informed consent, and written consent must have been obtained prior to any study procedures. 8. Patients/LAR must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires.
Exclusion criteria
Exclusion criteria: 1. Pregnant women, nursing mothers or a planned pregnancy within 18 months of participation. 2. Patients with T-cell related SCID 3. Patients with secondary immunodeficiency diseases 4. History or presence of any form of cancer prior to enrolment. 5. History of any autoimmune disease 6. Positive at screening for any markers of infectious bloodborne viruses 7. History of adverse or allergic reactions to other IgG or blood products 8. Patients with selective IgA deficiency or antibodies to IgA 9. History of acute renal failure or severe renal impairment, or deep venous thrombosis which in the opinion of the Investigator, may place the patient at unacceptable risk for study participation and may prevent the patient from completing the study 10. History of congestive heart failure [New York Heart Association class III/IV] or unstable angina. 11. Recent history of migraine, hyperprolinemia, and lymphoid malignancy. 12. Requirement for use of glucocorticosteroids above 0.15 mg of prednisone equivalent/kg/day and of other immunosuppressive drugs as concomitant medication 13. History or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in the opinion of the Investigator, may place the patient at unacceptable risk for study participation and may prevent the patient from completing the study. 14. Participation in any clinical study within the previous 3 months 15. Patient, who in the opinion of the Investigator, is not suitable for participation in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Purpose: To evaluate the efficacy & safety of ImmunoRel® in patients with primary immunodeficiency. Primary Objective: To study the efficacy of ImmunoRel® in patients of PID Primary End Point: The primary efficacy endpoint will be the incidence of acute serious bacterial infections per patient at 52 weeksTimepoint: The primary endpoint of this study, incidence of acute serious bacterial infection per patient, will be analysed at 52 weeks for all the patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): To evaluate other efficacy parameters, safety parameters and pharmacokinetic parameters of ImmunoRelTimepoint: 52 weeks | — |
Countries
India, Turkey
Contacts
Public ContactManoj Mavelil
Reliance Life Sciences Pvt. Ltd. (RLS)
Outcome results
None listed