TerminatedPhase 2

Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)

Stopped: Following the failure to demonstrate efficacy in EIG-UBX-001, the sponsor decided to terminate Study EIG-UBX-002.

United States51 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕. 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

What they're measuring

Treatment-emergent Adverse Events (TEAEs)

Timeframe: At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-up

Trial details

NCT IDNCT02736149

SponsorEiger BioPharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03

Results submitted2022-11-03

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials