Trial Outcomes & Findings for Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion (NCT NCT02752633)

Last Updated: 2024-04-09

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

7, 21 and 42 days

Results posted on

2024-04-09

Participant milestones
Measure	Allopurinol/Febuxostat Treatment This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Allopurinol/Febuxostat Treatment This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
Overall Study Withdrawal by Subject	1

Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion

Baseline characteristics by cohort
Measure	Allopurinol/Febuxostat Treatment n=9 Participants This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Race · Asian	0 Participants n=5 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Race · Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) Race · White	9 Participants n=5 Participants
Race (NIH/OMB) Race · More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Iceland	9 participants n=5 Participants

Timeframe: 7, 21 and 42 days

Outcome measures
Measure	Allopurinol/Febuxostat Treatment n=8 Participants Following a 7 day washout period all patients receive allopurinol (400 mg/day) as a single daily dose for 2 weeks. Following another 7 day washout period all participants receive febuxostat, 80 mg/day as a single daily dose, for 2 weeks. Allopurinol: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency. Febuxostat: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
Urinary 2,8-dihydroxyadenine Excretion Baseline	116 mg/24-h Interval 75.0 to 289.0
Urinary 2,8-dihydroxyadenine Excretion On allopurinol treatment	45 mg/24-h Interval 13.0 to 112.0
Urinary 2,8-dihydroxyadenine Excretion On febuxostat treatment	13 mg/24-h Interval 10.0 to 13.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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