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Treatment of Adult-Onset Immunodeficiency With Bortezomib

NCT03103555 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-04-06

No results posted yet for this study

Summary

This is pilot study aimed to investigate the application of proteosome inhibitor, Bortezomib in treatment of patients with neutralizing autoantibody to IFN-γ. The investigators hypothesis is that bortezomib will reduce the antibody level and restore interferon-gamma function, resulting in clinical improvement and should be well-tolerated and safe for use in patients with autoantibody to IFN-γ.

Conditions

  • Adult-onset Immunodeficiency

Interventions

DRUG

Bortezomib

Bortezomib will be subcutaneously administered in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle.

DRUG

Cyclophosphamide

Low dose cyclophosphamide will be given orally for 4 month after completion 2 cycles of bortezomib

Sponsors & Collaborators

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • Mahidol University

    lead OTHER

Principal Investigators

  • Nasikarn Angkasekwinai, MD. · Faculty of Mdicine Siriraj Hospital, Mahidol University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2018-11-01
Completion
2019-11-01

Countries

  • Thailand

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 NCT03103555 on ClinicalTrials.gov