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The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children

NCT03692416 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-02-15

No results posted yet for this study

Summary

Vasculitis denotes affection of small to medium sized vessels by polyangitis. Antineutrophil cytoplasmic antibodies (ANCA) are immunoglobulin G (IgG) autoantibodies directed against constituents of neutrophil granules leading to neutrophil degeneration which results in cell apoptosis known as "Natoptosis" (NaTosis) of the cells. These lead to vessel endothelial cell damage. So that, ANCA formation seems to be the basic reaction in vasculitis.

Complement activation at C3 and C4 was thought to be involved in renal damage ANCA associated vasculitis (AAV).

Conditions

  • Vasculitis

Interventions

DRUG

Ibuprofen

Infants and children with vasculitis attending AssiutU, aged \> 1 mo. - 17 yr. of both genders will be included during 2 years of study. Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests \& Albumin / creatinine ratio. All cases will have an initial estimation as well as follow up estimation after treatment by Ibuprofen for ANCA, C3, C4 \&C5a levels done, measured By ELISA technique.

DRUG

Prednisone

Infants and children with vasculitis attending AssiutU, aged \> 1 mo. - 17 yr. of both genders will be included during 2 years of study. Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests \& Albumin / creatinine ratio. All cases will have an initial estimation as well as follow up estimation after treatment by Steroids for ANCA, C3, C4 \&C5a levels done, measured By ELISA technique.

DRUG

Methotrexate

Infants and children with vasculitis attending AssiutU, aged \> 1 mo. - 17 yr. of both genders will be included during 2 years of study. Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests \& Albumin / creatinine ratio. All cases will have an initial estimation as well as follow up estimation after treatment by Methotrexate for ANCA, C3, C4 \&C5a levels done, measured By ELISA technique.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Safiea AF El-Deeb, PROF · Assiut University Child Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-11
Primary Completion
2021-11-11
Completion
2022-05-11

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

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 NCT03692416 on ClinicalTrials.gov