Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex, IHC (Histoglob) i… (NCT07680413) | Clinical Trial Compass
RecruitingNot Applicable
Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex, IHC (Histoglob) in Chronic Urticaria
India600 participantsStarted 2025-12-31
Plain-language summary
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.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patients aged ≥13 years.
. Able and willing to provide written informed consent (or assent where applicable).
. Diagnosed with chronic urticaria with UAS7 prior to enrollment already on first line of treatment for Chronic Urticaria
. Prescribed Histoglob injections for the first time at the discretion of treating physician as part of routine car
Exclusion criteria
. Known allergy or hypersensitivity to Histoglob or human immunoglobulin product.
. Patients with acute allergic attack
. Pregnant or lactating women.
. History of malignancy or any condition requiring immunosuppressive therapy other than study indication.
. Participation in any other clinical study.
. Any other condition or circumstance that, in the opinion of the study physician, makes the patient unsuitable for study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in clinical improvement as assessed by Urticaria Activity Score (UAS7)
Timeframe: End of study, approximately 1 year
Trial details
NCT IDNCT07680413
SponsorBharat Serums and Vaccines Limited
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2026-09
Contact for this trial
Dr.Saswata Banerjee, Vice President Medical Affairs