Double-blind placebo-controlled clinical trial of thalidomide for chronic granulomatous disease-associated colitis

Phase 2

Recruiting

• Conditions: chronic granulomatous disease-associated colitis; primary immunodeficiency diseases; inflammatory bowel disease; D006105

• Registration Number: JPRN-jRCT2031200236
• Lead Sponsor: Kawai Toshinao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1) Diagnosis of CGD colitis, ages over one year
2) Moderate CGD colitis (35 /<= PUCAI < 65), or Mild CGD colitis (10 /<= PUCAI <35) carrying bloody stool or over six times of defecation at the onset or relapse
3) Signed informed consent form agreeing to the clinical trial participation
4) Informed consent to compliance rules including administration of investigational agent and contraception

Exclusion Criteria

1) Patients allergic to the drug ingredients
2) Patients with HIV infection
3) Cancer except granuloma
4) Macrophage activating syndrome
5) Any mental problem
6) Pregnant or breast-feeding woman
7) Taking thalidomide or having a history of thalidomide administration
8) Oral, intravenous, or enema administration of steroid within four weeks of providing informed consent
9) Administration of immunomodulator within eight weeks of providing informed consent
10) A history of any biological agent administration
11) Miner who do not have guardian for appropriate administration of investigational agent
12) In certain circumstances that the researchers determined it was not suitable for the research

Study & Design

• Study Type: Interventional
• Study Design: Not specified