Trial Outcomes & Findings for Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients (NCT NCT01784523)
NCT ID: NCT01784523
Last Updated: 2021-09-14
Results Overview
To determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
11 participants
Primary outcome timeframe
2 years
Results posted on
2021-09-14
Participant Flow
Participant milestones
| Measure |
Standard Treatment
patients randomized to standard treatment will not receive hydroxychloroquine.
|
Hydroxychloroquine
Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing \<60kg; and 400 mg daily (200 mg twice a day)for patients weighing \>60kg.
Hydroxychloroquine
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Standard Treatment
patients randomized to standard treatment will not receive hydroxychloroquine.
|
Hydroxychloroquine
Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing \<60kg; and 400 mg daily (200 mg twice a day)for patients weighing \>60kg.
Hydroxychloroquine
|
|---|---|---|
|
Overall Study
Study closed early
|
7
|
4
|
Baseline Characteristics
Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients
Baseline characteristics by cohort
| Measure |
Standard Treatment
n=7 Participants
patients randomized to standard treatment will not receive hydroxychloroquine.
|
Hydroxychloroquine
n=4 Participants
Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing \<60kg; and 400 mg daily (200 mg twice a day)for patients weighing \>60kg.
Hydroxychloroquine
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
45.75 years
STANDARD_DEVIATION 7.89 • n=7 Participants
|
44.64 years
STANDARD_DEVIATION 8.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period.
Outcome measures
| Measure |
Standard Treatment
n=7 Participants
patients randomized to standard treatment will not receive hydroxychloroquine.
|
Hydroxychloroquine
n=4 Participants
Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing \<60kg; and 400 mg daily (200 mg twice a day)for patients weighing \>60kg.
Hydroxychloroquine
|
|---|---|---|
|
Number of Participants With an Acute Thrombosis Event
|
0 Participants
|
0 Participants
|
Adverse Events
Standard Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydroxychloroquine
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