Primary Immunodeficiency Diseases (PID)Phase 3VBPL-IVIGP3NCT07017036
Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients
A Phase 3 study testing IVIG-VImmune and IVIG-Immuglo in people with Primary Immunodeficiency Diseases (PID), run by Virchow Group at 2 sites in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID)
- What is being tested?
- IVIG-VImmune and IVIG-Immuglo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jul 2025to 1 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
- -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.
Who cannot join
- 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
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- 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
- Patient, who in the opinion of the Investigator, is not suitable for participation in the clinical study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites
Jyoti Nursing Home (P) Ltd.
Jaipur, Rajasthan, 302013
All India Institute of Medical Sciences
Nagpur, Maharashtra, 441108
Santosh Rathod Dr., MBBS, MD, DM Clinical Hematolo, 9545549174, Drsgrathod2007@gmail.com
About this study
Official title: 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
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
Read the 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)
- Being tested
- IVIG-VImmune, IVIG-Immuglo
- Keywords
- Primary Immunodeficiency Diseases (PID)
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIG-VImmuneDrug
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-ImmugloDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: IVIG-Immuglo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary - Incidence of acute serious bacterial infections
incidence of acute serious bacterial infections per patient will be assessed at 52 weeks
Measured: 52 weeks
Secondary outcomes (3)
Secondary - Pharmacokinetics
To assess the Ig serum concentration - Cmax
Measured: 52 weeks
Secondary Pharmacokinetics
To assess the IgG serum concentration Tmax
Measured: 52 weeks
Safety of IVIG
Safety will be assessed
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment - Randomized - parallel group study
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virchow Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017036
- Sponsor's protocol ID
- VBIVIG/2024-CT1
- Other IDs
- VBIVIG/2024-CT1
- Acronym
- VBPL-IVIGP3
- Status last verified
- May 2025
- First submitted
- 10 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07017036
- Acronym / sponsor ID
- VBPL-IVIGP3 / VBIVIG/2024-CT1
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Keywords
- Primary Immunodeficiency Diseases (PID)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Virchow GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment - Randomized - parallel group study
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Drug: IVIG-VImmune200-800 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 | Active comparator | Drug: IVIG-ImmugloImmuglo 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 |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Patients must be able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIG-VImmuneV-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 | Test Arm |
| IVIG-ImmugloImmuglo 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 | Reference |
Primary outcome
Primary - Incidence of acute serious bacterial infections
Time frame: 52 weeks
incidence of acute serious bacterial infections per patient will be assessed at 52 weeks
3 secondary outcomes
Secondary - Pharmacokinetics
Time frame: 52 weeks
Secondary Pharmacokinetics
Time frame: 52 weeks
Safety of IVIG
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IVIG-VImmune and IVIG-Immuglo in people with Primary Immunodeficiency Diseases (PID), run by Virchow Group at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asha M Dr., MBBS, MD Respiratory Medicine (7022327317, jyotihospitalclinicalresearch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary - Incidence of acute serious bacterial infections (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.