An observational study in Chronic Urticaria, sponsored by Bharat Serums and Vaccines Limited. Completed at 40 sites in India. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Bharat Serums and Vaccines Limited · Observational
This is a prospective, multicentre, non-interventional, observational, real-world evidence (RWE) study designed to evaluate the effectiveness and safety of Immunoglobulin/Histamine Complex (IHC) in patients with Chronic Urticaria in India.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's enrollment of 660 is above the median of 165 across 40 observational studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Bharat Serums and Vaccines Limited is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male or female patients aged above 13 years diagnosed with chronic urticaria with UAS7
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with Chronic Urticaria on the first line of treatment like antihistaminics and not controlled requiring histaglobulin treatment
Drug: Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection
Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose.
Change in clinical improvement as assessed by Urticaria Activity Score (UAS7)
Proportion of patients achieving UAS7 \<7
Time frame: End of study, approximately 1 year
Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden):
\- Change in the requirement of regular anti-allergic medications (including dose increase/ decrease/or complete discontinuation) from baseline to 2 months.
Time frame: baseline to 2 months
3. Change in Quality of Life:
• Proportion of patients showing improvement in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) score from baseline to 2 months.
Time frame: Baseline to 2 months
4. Safety and Tolerability:
Incidence, severity, and relationship of adverse events (AEs) treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) during the study period.
Time frame: Throughout the study period, an average of 1 year
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Bharat Serums and Vaccines Limited