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Following the failure to demonstrate efficacy in EIG-UBX-001, the sponsor decided to terminate Study EIG-UBX-002.
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ubenimex | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ubenimex | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events (TEAEs) | Number of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form | At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-up |
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Inclusion Criteria:
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.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Heart Center Foundation, An Affiliate of Cedars-Sinai Heart Institute, Cedars-Sinai Medical Care Foundation | Beverly Hills | California | 90211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23986401 | Background | Tian W, Jiang X, Tamosiuniene R, Sung YK, Qian J, Dhillon G, Gera L, Farkas L, Rabinovitch M, Zamanian RT, Inayathullah M, Fridlib M, Rajadas J, Peters-Golden M, Voelkel NF, Nicolls MR. Blocking macrophage leukotriene b4 prevents endothelial injury and reverses pulmonary hypertension. Sci Transl Med. 2013 Aug 28;5(200):200ra117. doi: 10.1126/scitranslmed.3006674. | |
| 26558820 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2021 |
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| UCSD Medical Center | La Jolla | California | 92103 | United States |
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
| Harbor - UCLA Medical Center | Torrance | California | 90502 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Cleveland Clinic, Florida | Weston | Florida | 33331 | United States |
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | 40202 | United States |
| Chest Medicine Associates | South Portland | Maine | 04106 | United States |
| Johns Hopkins University, Pulmonary and Critical Care Medicine | Baltimore | Maryland | 21205 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| University of Michigan | Ann Arbor | Michigan | 48103 | United States |
| Mayo Clinic College of Medicine | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Respiratory Institute | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pennsylvania Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Alpert Medical School of Brown University Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University Texas Health Science Center | San Antonio | Texas | 78229 | United States |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Qian J, Tian W, Jiang X, Tamosiuniene R, Sung YK, Shuffle EM, Tu AB, Valenzuela A, Jiang S, Zamanian RT, Fiorentino DF, Voelkel NF, Peters-Golden M, Stenmark KR, Chung L, Rabinovitch M, Nicolls MR. Leukotriene B4 Activates Pulmonary Artery Adventitial Fibroblasts in Pulmonary Hypertension. Hypertension. 2015 Dec;66(6):1227-1239. doi: 10.1161/HYPERTENSIONAHA.115.06370. Epub 2015 Oct 5. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Mean pulmonary artery pressure | Mean | Standard Deviation | millimetre of mercury (mmHg) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment-emergent Adverse Events (TEAEs) | Number of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form | Posted | Count of Participants | Participants | At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-up |
|
|
|
Up to 24 weeks of treatment from baseline with 4 weeks of follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ubenimex | 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. | 1 | 51 | 12 | 51 | 42 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right ventricular failure | Cardiac disorders | Systematic Assessment |
| ||
| Syncope | Vascular disorders | Systematic Assessment |
| ||
| Device occlusion | General disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Ulcer | General disorders | Systematic Assessment |
| ||
| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wound drainage / | Surgical and medical procedures | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| oedema peripheral | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior VP, Clinical Development | Eiger BioPharmaceuticals, Inc. | 1-650-272-6138 | info@eigerbio.com |
| Apr 13, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C012211 | ubenimex |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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