Pulmonary Arterial Hypertension
Conditions
Brief summary
Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization \[WHO\] Group 1) to improve exercise capacity and delay clinical worsening. This study is a Phase 2, open-label, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001.
Detailed description
This study is a Phase 2, open-label, multicenter, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001 (Study EIG-UBX-001 is a Phase 2, randomized, double-blind, placebo-controlled clinical trial) and meet the eligibility criteria for Study EIG-UBX-002. The primary objective for this study is: \- to obtain long-term safety and tolerability data for ubenimex (150 mg administered three times daily \[TID\]) in patients with PAH (WHO Group 1).
Interventions
DRUGubenimex
Sponsors
Eiger BioPharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have completed Study EIG-UBX-001 through Week 24. * In the opinion of the Principal Investigator, has been generally compliant with study requirements during Study EIG-UBX-001. * Agrees to use a medically acceptable method of contraception throughout the entire study period. * Willing and able to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.
Exclusion criteria
* Is pregnant or lactating. * Concurrent regular use of another leukotriene pathway inhibitor. * Any reason that, in the opinion of the investigator, precludes the patient from participating in the study. 1. Any condition that is unstable or that could jeopardize the safety of the patient and his/her compliance in the study 2. A serious uncontrolled medical disorder/condition that in the opinion of the investigator would impair the ability of the patient to receive protocol therapy * An ongoing, drug-related, serious adverse event (SAE). * Significant/chronic renal insufficiency. * Transaminases (alanine transaminase, aspartate transaminase) levels \>3 × upper limit of normal (ULN) and/or bilirubin level \>2 × ULN. * Absolute neutrophil count \<1500 mm3. * Hemoglobin concentration \<9 g/dL at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent Adverse Events (TEAEs) | At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-up | Number of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Ubenimex |
|---|---|
| Age, Continuous | 51.8 years |
| Mean pulmonary artery pressure | 45.43 millimetre of mercury (mmHg) STANDARD_DEVIATION 9.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 51 |
| other Total, other adverse events | 42 / 51 |
| serious Total, serious adverse events | 12 / 51 |
Outcome results
Primary
Treatment-emergent Adverse Events (TEAEs)
Number of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form
Time frame: At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ubenimex | Treatment-emergent Adverse Events (TEAEs) | 44 Participants |