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Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)

NCT06250400 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2024-02-09

No results posted yet for this study

Summary

The goal of this clinical trial is to study patients with chronic spontaneous urticaria. The main question it aims to answer is the efficacy and safety of histamine human immunoglobulin (ShuYangMinNing) in the treatment of chronic spontaneous urticaria.

Conditions

Interventions

BIOLOGICAL

human histaglobulin

once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;

BIOLOGICAL

placebo

once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;

DRUG

Loratadine 10 Mg

orally, 10mg once a day for 4 weeks

Sponsors & Collaborators

  • Hangzhou Grand Biologic Pharmaceutical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-07-01
Completion
2025-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250400 on ClinicalTrials.gov