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Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients

ConditionPrimary Immunodeficiency Diseases (PID)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-65
SponsorVirchow Group

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

WBC ≥3.5 x 109/L

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Test ArmExperimental treatment 1 intervention
Group B: ReferenceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary - Incidence of acute serious bacterial infections

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

Time frame
52 weeks

Secondary outcomes

1

Secondary - Pharmacokinetics

To assess the Ig serum concentration - Cmax

Time frame
52 weeks
2

Secondary Pharmacokinetics

To assess the IgG serum concentration Tmax

Time frame
52 weeks
3

Safety of IVIG

Safety will be assessed

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virchow Group

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: