NCT07680413 Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex, IHC (Histoglob) in Chronic Urticaria
| NCT ID | NCT07680413 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bharat Serums and Vaccines Limited |
| Condition | Chronic Urticaria |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-12-31 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2025-12-31 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged ≥13 years. 2. Able and willing to provide written informed consent (or assent where applicable). 3. Diagnosed with chronic urticaria with UAS7 prior to enrollment already on first line of treatment for Chronic Urticaria 4. Prescribed Histoglob injections for the first time at the discretion of treating physician as part of routine car Exclusion Criteria: 1. Known allergy or hypersensitivity to Histoglob or human immunoglobulin product. 2. Patients with acute allergic attack 3. Pregnant or lactating women. 4. History of malignancy or any condition requiring immunosuppressive therapy other than study indication. 5. Participation in any other clinical study. 6. Any other condition or circumstance that, in the opinion of the study physician, makes the patient unsuitable for study participation
Contact & Investigator
Dr.Saswata Banerjee, Vice President Medical Affairs
✉ saswata.banerjee@bsvgroup.com📞 +91 02245043456
Dr Saswata Banerjee
STUDY DIRECTOR
Bharat serums and Vaccines LTd
Frequently Asked Questions
Who can join the NCT07680413 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying Chronic Urticaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07680413 currently recruiting?
Yes, NCT07680413 is actively recruiting participants. Contact the research team at saswata.banerjee@bsvgroup.com for enrollment information.
Where is the NCT07680413 trial being conducted?
This trial is being conducted at Ahmedabad, India, Ahmedabad, India, Ahmedabad, India, Vadodara, India and 11 additional locations.
Who is sponsoring the NCT07680413 clinical trial?
NCT07680413 is sponsored by Bharat Serums and Vaccines Limited. The principal investigator is Dr Saswata Banerjee at Bharat serums and Vaccines LTd. The trial plans to enroll 600 participants.