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NCT Number: NCT07680413

Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex, IHC (Histoglob) in Chronic Urticaria

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.

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Key information

Conditions

Chronic Urticaria Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

L. G. Hospital, Ahmedabad, Gujarat, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection

Drug

Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose.

Primary outcomes

  1. Change in clinical improvement as assessed by Urticaria Activity Score (UAS7)

    Time frame: End of study, approximately 1 year

    Proportion of patients achieving UAS7 <7

Secondary outcomes

  1. Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden):

    Time frame: baseline to 2 months

    • Change in the requirement of regular anti-allergic medications (including dose increase/ decrease/or complete discontinuation) from baseline to 2 months.

  2. 3. Change in Quality of Life:

    Time frame: Baseline to 2 months

    • Proportion of patients showing improvement in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) score from baseline to 2 months.

  3. 4. Safety and Tolerability:

    Time frame: Throughout the study period, an average of 1 year

    Incidence, severity, and relationship of adverse events (AEs) treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) during the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr.Falgun Vyas, MBBS, MD

CONTACT

[email protected]

+91 02245043456

Dr.Saswata Banerjee, Vice President Medical Affairs

CONTACT

[email protected]

+91 02245043456

Sponsors and collaborators

Lead sponsor

Bharat Serums and Vaccines Limited

Industry

Collaborators

  • Innvocept Global Solutions Private Limited

Registry information

Official study title

Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex; IHC (Histoglob) in the Management of Chronic Urticaria: A Prospective, Multicenter, Observational Study.

Acronym: RUSH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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