NCT07017036

Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients

An Open- Label, Multicentre, Phase III Clinical Comparative Study to Evaluate the Efficacy, Safety and Pharmacokinetic Properties of Human Normal Immunoglobulin in Patients With Primary Immunodeficiency Disease

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Virchow Group · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Eligible subjects will receive either test or reference as per the randomization in 1:1 ratio. Test group: 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. Reference group: 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

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
DRUG	IVIG-VImmune	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
DRUG	IVIG-Immuglo	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

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-06-12
• Last updated: 2025-06-12

Locations

2 sites across 1 country: India