Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) (LIBERTY2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02736149 |
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Recruitment Status :
Terminated
(Following the failure to demonstrate efficacy in EIG-UBX-001, the sponsor decided to terminate Study EIG-UBX-002.)
First Posted : April 13, 2016
Results First Posted : January 18, 2023
Last Update Posted : January 18, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Arterial Hypertension | Drug: ubenimex | Phase 2 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 51 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) |
| Study Start Date : | December 2016 |
| Actual Primary Completion Date : | March 2018 |
| Actual Study Completion Date : | August 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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. |
Drug: ubenimex
Other Name: UBX |
- Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
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Any reason that, in the opinion of the investigator, precludes the patient from participating in the study.
- Any condition that is unstable or that could jeopardize the safety of the patient and his/her compliance in the study
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736149
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Documents provided by Eiger BioPharmaceuticals:
| Responsible Party: | Eiger BioPharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02736149 |
| Other Study ID Numbers: |
EIG-UBX-002 |
| First Posted: | April 13, 2016 Key Record Dates |
| Results First Posted: | January 18, 2023 |
| Last Update Posted: | January 18, 2023 |
| Last Verified: | December 2022 |
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Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension Hypertension, Pulmonary Lung Diseases Ubenimex Vascular Diseases Cardiovascular Diseases Respiratory Tract Diseases Adjuvants, Immunologic Immunologic Factors |
Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents |