Trial Outcomes & Findings for Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease (NCT NCT01472874)
NCT ID: NCT01472874
Last Updated: 2020-04-15
Results Overview
Alanine transaminase
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Pre Treatment (mean)
Results posted on
2020-04-15
Participant Flow
Participant milestones
| Measure |
Once a Day Trientine
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease
Baseline characteristics by cohort
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
|
Prior Treatment
zinc acetate
|
2 participants
n=5 Participants
|
|
Prior Treatment
d-penicillamine
|
1 participants
n=5 Participants
|
|
Prior Treatment
trientine BID
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre Treatment (mean)Alanine transaminase
Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
ALT
|
41.38 U/L
Standard Deviation 31.81
|
PRIMARY outcome
Timeframe: Months 1,2,3,6,9,12 (mean)Alanine transaminase
Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
ALT
|
50.89 U/L
Standard Deviation 32.29
|
PRIMARY outcome
Timeframe: Pre Treatment (mean)Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Cu Serum
|
0.54 mcg/24h
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: Months 1,2,3,6,9,12 (mean)Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Cu Serum
|
0.52 mcg/24h
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Pre Treatment (mean)The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy
Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
INR
|
0.99 international normalized ratio
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Months 1,2,3,6,9,12 (mean)The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy
Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
INR
|
1.05 international normalized ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Pre Treatment (mean)Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Albumin
|
0.54 g/dL
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Months 1,2,3,6,9,12 (mean)Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Albumin
|
0.52 g/dL
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Pre Treatment (mean)Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Cu Urine
|
287.9 mcg/24hr
Standard Deviation 259.1
|
SECONDARY outcome
Timeframe: Months 1,2,3,6,9,12 (mean)Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Cu Urine
|
313.4 mcg/24hr
Standard Deviation 191.7
|
SECONDARY outcome
Timeframe: Pre Treatment (mean)Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Zn Urine
|
1959 mcg/24hr
Standard Deviation 2214
|
SECONDARY outcome
Timeframe: Months 1,2,3,6,9,12 (mean)Outcome measures
| Measure |
Once a Day Trientine
n=8 Participants
Patients receive once a day trientine
Once a day Trientine: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
|
|---|---|
|
Zn Urine
|
2214 mcg/24hr
Standard Deviation 1346
|
Adverse Events
Once a Day Trientine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place