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NCT Number: NCT07486583

Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.

To evaluate the efficacy of Autologous Whole Blood Therapy versus conventional treatment using fourfold dose of antihistamines in Autologus serum skin test (ASST) positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action.

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Key information

Conditions

Chronic Idiopathic Urticaria Chronic Disease Chronic Urticaria 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

To evaluate the efficacy of Autologous Whole Blood Therapy (AWBT) versus conventional treatment using fourfold dose of antihistamines in ASST positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action. Also, assessment of serum levels of D-dimer, IFN-γ, IL-6, anti-IgE IgG before and after treatment.

All patients will take desloratadine 10 mg at four-fold dose daily The AWBT test group patients will receive 8 doses of autologous whole blood therapy (AWBT) once weekly. The first dose will be 2.5ml and subsequent doses will be 5ml of venous blood, which will be drawn from any accessible vein under aseptic precautions. The blood will be re-injected immediately by deep intramuscular injection (IM) on alternate gluteal regions.

Patients will be advised to record the 7-day urticaria activity score (UAS 7) based on a simple questionnaire, on day 0, 4th week and 8th week of the treatment (End of Therapy (EOT)), and in the follow up period after 4 weeks following EOT (End of Study (EOS)). Dermatology life quality index (DLQI) will be assessed before treatment and at the end of therapy (8 weeks).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Chronic idiopathic urticaria patients of both sexes aging 18 years of age or older who are unresponsive to four-fold of antihistamines.

Exclusion criteria

  • other types of chronic urticaria
  • Pregnancy
  • Lactation
  • Immunocompromised patients
  • Patients on Systemic corticosteroid or immunosuppressive drugs used in the past 6 weeks
  • History of Bronchial Asthma
  • Patients on anticoagulants
  • Patients on non-steroidal anti-inflammatory drugs

Treatment and study plan

Autologous whole blood therapy

Biological

The AWBT test group patients will receive 8 doses of autologous whole blood therapy (AWBT) once weekly. The first dose will be 2.5ml and subsequent doses will be 5ml of venous blood, which will be drawn from any accessible vein under aseptic precautions. The blood will be re-injected immediately by deep intramuscular injection (IM) on alternate gluteal regions.

desloratadine

Drug

All patients will take desloratadine 10 mg at four-fold dose daily

Primary outcomes

  1. change in urticaria activity score (UAS7) from baseline to 8 weeks

    Time frame: 12 months

    Change in 7-day urticaria activity score (UAS7) score from baseline to 8 weeks after treatment with either AWBT with fourfold antihistamines or fourfold of antihistamines alone in Chronic Idiopathic Urticaria (CIU) patients.

    urticaria activity score7 ranges from 0-42. A score of 0 means complete remission while score (28-42) means severe disease

Secondary outcomes

  1. correlation between ASST result and treatment response

    Time frame: 12 months

    correlation between autologous serum skin test (ASST) result (positive/negative) and change in UAS7 score after 8 weeks of treatment. ASST positivity will be assessed as a binary variable(positive/negative), and treatment response will be measured as the change in UAS7

  2. correlation between serum biomarkers and treatment response

    Time frame: 12 months

    correlation between baseline serum levels of interferon-gamma (IFN-γ), interleukin-6(IL-6) and anti-IgE IgG antibodies and change in UAS7 score after 8 weeks of treatment. serum biomarkers will be measured using ELISA and expressed in pg/ml (for IFN-γ, IL-6) and optical density or concentration units for anti-IgE IgG.

Study contacts

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

Ahmed Mourad, MD

CONTACT

[email protected]

00201021534245

Sarah Elsayed, MSc, MBBCh

CONTACT

[email protected]

00201094077370

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Autologous Whole Blood Therapy in Autologous Serum Skin Test (ASST) Positive and Negative Chronic Idiopathic Urticaria Patients, a Clinical and Biochemical Randomized Controlled Trial.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 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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