Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients

NCT07017036 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: VBIVIG/2024-CT1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The study duration for individual patients will be up to 55 weeks for the 4-weekly and 3- weekly schedule of the treatment which includes 3 weeks for screening, 48 weeks for Study Medication administration and 4 weeks for follow-up assessments

Conditions

Primary Immunodeficiency Diseases (PID)

Keywords

Primary Immunodeficiency Diseases (PID)

Outcome Measures

Primary Outcomes (1)

• Primary - Incidence of acute serious bacterial infections

  incidence of acute serious bacterial infections per patient will be assessed at 52 weeks

  52 weeks

Secondary Outcomes (3)

• Secondary - Pharmacokinetics

  52 weeks

• Secondary Pharmacokinetics

  52 weeks

• Safety of IVIG

  52 weeks

Study Arms (2)

Test Arm

EXPERIMENTAL

200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose.

Drug: IVIG-VImmune

Reference

ACTIVE COMPARATOR

Immuglo will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose

Drug: IVIG-Immuglo

Interventions

IVIG-VImmune DRUG

V-Immune will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose

Test Arm

IVIG-Immuglo DRUG

Immuglo will be administered at 200-800 mg/kg dose as a single infusion every 3 or 4 weeks. Patients will be treated with V-Immune from Week 0 (first dose) till Week 48 at an investigator-recommended dose

Reference

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 2 to 65 years.
• Patients with confirmed diagnosis of primary immunodeficiency, predominantly antibody deficient, or common variable immunodeficiency (CVID) with a history of hypogammaglobulinemia (i.e., IgG\<500 mg/dl) or X-linked agammaglobulinemia (XLA).
• Treatment naive 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.
• The screening laboratory tests must meet the following criteria:
• WBC ≥3.5 x 109/L
• Neutrophils ≥1.5 x 109/L
• Platelets ≥100 x 109/L
• Serum transaminase ≤2 times the upper limit of normal
• Alkaline phosphatase levels ≤2 times the upper limit of normal
• Serum creatinine ≤150 µmol/L (≤1.7mg/dl)
• Patients must be able to adhere to the study visit schedule and other protocol requirements.
• If subject is a female and is
• a. -of child bearing potential, she should be practicing an acceptable method of birth control for the duration of tl1e 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
• Patients/LAR must be capable of giving informed consent, and written consent must have been obtained prior to any study procedures.

You may not qualify if:

• Pregnant women, nursing mothers or a planned pregnancy within 18 months of participation.
• Patients requires any blood transfusion during the study.
• Patients with T-cell related Severe combined immunodeficiency.
• Patients with secondary immunodeficiency diseases
• History or presence of any form of cancer prior to enrollment.
• History of any autoimmune disease
• Positive at screening for any markers of infectious blood borne viruses
• History of adverse or allergic reactions to other IgG or blood products
• Patients with selective IgA deficiency or antibodies IgA
• 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.
• History of congestive heart failure \[New York Heart Association class III/IV\] or unstable angina
• Recent history of migraine, hyperprolinemia, and lymphoid malignancy.
• Requirement for use of glucocorticosteroids above 0.15 mg of prednisone equivalent/kg/day and other immunosupressive drugs as concomitant medication.
• 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.
• Participation in any clinical study within the previous 3 months

Sponsors & Collaborators

• Virchow Group: lead

Study Sites (2)

All India Institute of Medical Sciences

Nagpur, Maharashtra, 441108, India

Location

Jyoti Nursing Home (P) Ltd.

Jaipur, Rajasthan, 302013, India

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Asha M Dr., MBBS, MD Respiratory Medicine

CONTACT

7022327317; jyotihospitalclinicalresearch@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment - Randomized - parallel group study

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: June 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)