Trial Outcomes & Findings for Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) (NCT NCT02736149)
NCT ID: NCT02736149
Last Updated: 2023-01-18
Results Overview
Number of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-up
Results posted on
2023-01-18
Participant Flow
Participant milestones
| Measure |
Ubenimex
ubenimex capsules 150 mg three times a day (TID), administered orally, minimum of 24 weeks for all patients.
The maximum anticipated time an individual patient will participate will vary because treatment will continue until the last patient enrolled has received at least 24 weeks of open-label treatment.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
Baseline characteristics by cohort
| Measure |
Ubenimex
n=51 Participants
ubenimex capsules 150 mg three times a day (TID), administered orally, minimum of 24 weeks for all patients.
The maximum anticipated time an individual patient will participate will vary because treatment will continue until the last patient enrolled has received at least 24 weeks of open-label treatment.
|
|---|---|
|
Age, Continuous
|
51.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Mean pulmonary artery pressure
|
45.43 millimetre of mercury (mmHg)
STANDARD_DEVIATION 9.95 • n=5 Participants
|
PRIMARY outcome
Timeframe: At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-upNumber of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form
Outcome measures
| Measure |
Ubenimex
n=51 Participants
Ubenimex capsules 150 mg three times a day (TID), administered orally, minimum of 24 weeks for all patients. The maximum anticipated time an individual patient will participate will vary because treatment will continue until the last patient enrolled has received at least 24 weeks of open-label treatment.
|
|---|---|
|
Treatment-emergent Adverse Events (TEAEs)
|
44 Participants
|
Adverse Events
Ubenimex
Serious events: 12 serious events
Other events: 42 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ubenimex
n=51 participants at risk
ubenimex capsules 150 mg TID, administered orally, minimum of 24 weeks for all patients.
The maximum anticipated time an individual patient will participate will vary because treatment will continue until the last patient enrolled has received at least 24 weeks of open-label treatment.
|
|---|---|
|
Cardiac disorders
Right ventricular failure
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Vascular disorders
Syncope
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
General disorders
Device occlusion
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
General disorders
Ulcer
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Gastrointestinal disorders
Bowel obstruction
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Surgical and medical procedures
Wound drainage /
|
2.0%
1/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
Other adverse events
| Measure |
Ubenimex
n=51 participants at risk
ubenimex capsules 150 mg TID, administered orally, minimum of 24 weeks for all patients.
The maximum anticipated time an individual patient will participate will vary because treatment will continue until the last patient enrolled has received at least 24 weeks of open-label treatment.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
13.7%
7/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
6/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Metabolism and nutrition disorders
oedema peripheral
|
17.6%
9/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.7%
8/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
11.8%
6/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
|
Nervous system disorders
headache
|
11.8%
6/51 • Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
|
Additional Information
Senior VP, Clinical Development
Eiger BioPharmaceuticals, Inc.
Phone: 1-650-272-6138
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place