NIPH Clinical Trials Search

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	chronic granulomatous disease-associated colitis
Date of first enrollment	28/09/2017
Target sample size	8
Countries of recruitment
Study type	Interventional
Intervention(s)	1) Oral administration of thalidomide (1.5-3mg/kg), once a day 2) Oral administration of placebo (1.5-3mg/kg), once a day

Outcome(s)

Primary Outcome	Ratio of subjects decreasing more than 20 points of Pediatric ulcerative colitis activity index (PUCAI) or reaching less than 10 of PUCAI score at the end of double-blind trial
Secondary Outcome	Ratio of subjects reaching less than 10 of PUCAI score at the end of double-blind trial Ratio of subjects decreasing more than one point of physician's global assessment (PGA) at the end of double-blind trial

Key inclusion & exclusion criteria

Age minimum	>= 1age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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