CompletedPhase 2

Safety and Efficacy of BIA 5-1058 in PAH

Austria, Germany, Italy20 participantsStarted 2019-06-26

Plain-language summary

This study aims to assess the safety and tolerability of the individual highest tolerated zamicastat doses, achieved in the study BIA-51058-201, during long-term treatment in Pulmonary Arterial Hypertension (PAH) disease.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: For inclusion in the extension study, patients had to fulfil all of the following criteria at visit V1 (Day 1, start of the extension study): * Have performed MPV3 of the preceding study BIA-51058-201. * Able to comprehend and willing to sign an informed consent form (ICF). * For women: Agreed not to donate ova from the time of informed consent until 30 days after the last IMP intake. * For men: Agreed not to donate sperm from the time of informed consent until 90 days after the last IMP intake Exclusion Criteria: Patients were to be excluded for any one of the following reasons: * Significant non-compliance with the protocol during the preceding study BIA-51058-201 which may have an impact on this extension study. * WHO functional class IV as judged by the investigator (reference 1) * Two or more consecutive measurements of systolic blood pressure (SBP) \< 95 mmHg or diastolic blood pressure (DBP) \< 50 mmHg measured at visit V1. * Uncontrolled diabetes mellitus with HbA1c ≥ 8.5% within the last three months or at visit V1. * Occurrence of an AE during the preceding study which is judged by the investigator as contraindicative to further participation in the extension study. * Any disease known to cause pulmonary hypertension other than PAH WHO Group 1. * Obstructive lung disease: Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) \< 60% and FEV1 \< 60% of predicted value after bronchodilator administration, as demonstrated and doc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Up to 12 weeks

Clinically relevant changes in laboratory parameters: coagulation

Timeframe: From baseline to week 6 and week 12, and from day -1 to week 6 and week 12

Incidence of clinically relevant changes (abnormalities) in laboratory parameters: biochemistry

Timeframe: From baseline to week 6 and week 12, and from day -1 to week 6 and week 12

Incidence of clinically relevant changes (abnormalities) in laboratory parameters: haematology

Timeframe: From baseline to week 6 and week 12, and from day -1 to week 6 and week 12

Clinically relevant changes in laboratory parameters: urinalysis

Timeframe: From baseline to week 6 and week 12, and from day -1 to week 6 and week 12

Clinically relevant changes in laboratory parameters: arterial blood gas

Timeframe: From baseline to week 12, and from day -1 to week 12

Trial details

NCT IDNCT06009185

SponsorBial - Portela C S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-17

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