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Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.

ConditionChronic Idiopathic Urticaria
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

other types of chronic urticaria

Pregnancy

Lactation

Immunocompromised patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous whole blood therapy

    Biological/Vaccine

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: AWBT plus antihistaminesExperimental treatment 2 interventions
Group B: antihistamines aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
12 months

Secondary outcomes

1

correlation between ASST result and treatment response

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

Time frame
12 months
2

correlation between serum biomarkers and treatment response

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: