Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.

March 18, 2026 updated by: Sarah Elsayed Mahmoud Awad, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  1. other types of chronic urticaria
  2. Pregnancy
  3. Lactation
  4. Immunocompromised patients
  5. Patients on Systemic corticosteroid or immunosuppressive drugs used in the past 6 weeks
  6. History of Bronchial Asthma
  7. Patients on anticoagulants
  8. Patients on non-steroidal anti-inflammatory drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AWBT plus antihistamines
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.
Biological: Autologous whole blood therapy
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.
Drug: Desloratadine
All patients will take desloratadine 10 mg at four-fold dose daily
Active Comparator: antihistamines alone
All patients will take desloratadine 10 mg at four-fold dose daily
Drug: Desloratadine
All patients will take desloratadine 10 mg at four-fold dose daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-142-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Relevant participant data shall be provided to researchers who request them on reasonable basis

IPD Sharing Time Frame

from January 2027 indefinitely

IPD Sharing Access Criteria

access will be provided to deidentified data including all study parameters

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Idiopathic Urticaria

Clinical Trials on Autologous whole blood therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe