Study on Long-term Safety of Seralutinib for Patients with Pulmonary Arterial Hypertension

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment for Pulmonary Arterial Hypertension (PAH). PAH is a condition where the blood pressure in the arteries of the lungs is higher than normal, which can lead to heart problems. The treatment being tested is called seralutinib, which is taken as an inhalation powder in a hard capsule form. This means the medication is inhaled directly into the lungs to help manage the condition.

The purpose of the study is to evaluate how safe and tolerable seralutinib is for people with PAH over a long period. Participants in the study will continue using the medication and will be monitored for any side effects or changes in their condition. The study will also look at how the treatment affects the distance participants can walk in six minutes, which is a common way to measure physical ability in people with PAH.

Participants will be involved in the study for up to 52 weeks, during which they will have regular check-ups and tests to ensure their safety and to gather information about the treatment’s effects. The study will help researchers understand more about the long-term use of seralutinib and its potential benefits for people living with Pulmonary Arterial Hypertension.

1 enrollment

Upon joining the study, confirmation of completion of a prior seralutinib study is required.

Women of childbearing potential must undergo a pregnancy test to ensure a negative result before starting the treatment.

Participants must provide informed consent, acknowledging understanding of the study details.

2 treatment initiation

The treatment involves the use of seralutinib, administered as an inhalation powder in hard capsule form.

The medication is taken through inhalation, which is a method of breathing in the medicine.

3 treatment duration

The study aims to evaluate the long-term safety and tolerability of seralutinib in individuals with pulmonary arterial hypertension (PAH).

Participants are expected to adhere to the treatment plan, including scheduled visits and laboratory tests.

4 monitoring and assessments

Regular monitoring for any treatment-emergent adverse events (TEAEs) is conducted.

Secondary assessments include changes in the distance achieved on the six-minute walk test and changes in NT-proBNP levels, which are indicators of heart stress.

5 completion

The study is estimated to conclude by October 31, 2028.

Participants are required to comply with all study procedures until the end of the trial.

Who Can Join the Study?

  • Participants must have completed a previous study involving the investigational product, seralutinib, for Pulmonary Arterial Hypertension (PAH).
  • Women of childbearing potential must have a negative pregnancy test before starting the study. This test checks for a hormone called human chorionic gonadotropin (hCG), which indicates pregnancy.
  • Women who can become pregnant and are sexually active with a male partner must use a highly effective form of birth control during the study and for 30 days after the last dose of seralutinib. Acceptable methods include hormonal birth control (like pills, patches, implants, or injections), intrauterine devices, or other reliable methods. They should not donate eggs during this time.
  • Women of nonchildbearing potential include those who have had surgical procedures like removal of ovaries or fallopian tubes, or those who are post-menopausal. Post-menopausal means not having a period for 12 months or more after stopping hormone treatments, with certain hormone levels confirming this status.
  • Male participants who are sexually active with a female partner who can become pregnant must use a condom during the study and for 90 days after the last dose of seralutinib. They should not donate sperm during this time.
  • Participants must have signed a document called informed consent, which shows they understand the important details of the study before starting any study-related activities.
  • Participants must be willing and able to attend scheduled visits, follow the treatment plan, and complete laboratory tests and other study procedures.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Onassis Cardiac Surgery Center Kallithea Greece
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Bucharest Romania
Institutul Inimii De Urgenta Pentru Boli Cardiovasculare Niculae Stancioiu Cluj Napoca Romania
Mediprax Centrum S.R.L. Cluj Napoca Romania
Evangelismos S.A. Athens Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Klinikum Würzburg Mitte gGmbH Standort Missioklinik Medizinische Klinik mit Schwerpunkt Pneumologie Wuerzburg Germany
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nice Nice France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Rigshospitalet Copenhagen Denmark
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Servei De Salut De Les Illes Balears Palma Spain
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Hospital Costa del Sol Marbella Spain
Krankenhaus Neuwittelsbach Munich Germany
Oumsnqwwczhvuu Lzcb Ghju Linz Austria
Iznxxduxp Fij Ctqpjdbj Ayl Efzcexzpfwgm Mlrlvkll Prague Czechia
Mjownggczielowfduasojwlvnt Honeximhevfupjtv Halle (Saale) Germany
Hgwxlbat Uxcfnynwopmcw Mtyrlip Dw Vnlpbvcwsp Santander Spain
Lhltxmtjqe Uucajvxorr om Hwskpn Sxgrqrzb Kaunas Lithuania
Uzyygjyqcd Hnpzjxps Cmslbgu Cologne Germany
Aikvipvig Ugf Amsterdam The Netherlands
Ezuuzke Udoiaehtcdvg Mznfyzo Clbotvq Rvvshsgte (lwnuyet Mff Rotterdam The Netherlands
Aejbxl Uimnwucpcs Hlnjlnms Aarhus Denmark
Kytzugoe dea Uuoclnlqiojv Mttcxbcx Atr Munich Germany
Ahhtmbb Uvwny Sykuckaas Lmzqqo Dx Bqeaxxt Bologna Italy
Udyriwagov Dgfko Sdcui Dx Rifm Ld Stlppknl Rome Italy
Hmtnxejp Vgxl dhpjyzdk Barcelona Spain
Ulgricnqsy Gftxasy Hocifsej Aeujwun Athens Greece
Kmhhzdjii Ssxxjwi Sspfsgcejdrzeep ig Jfrx Pnzoj Ij Cracow Poland
Cci Kqnadax Bgjhgpg Le Kremlin-Bicetre France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.06.2024
Belgium Belgium
Not recruiting
30.06.2024
Czechia Czechia
Not recruiting
30.06.2024
Denmark Denmark
Not recruiting
30.06.2024
France France
Not recruiting
30.06.2024
Germany Germany
Not recruiting
30.06.2024
Greece Greece
Not recruiting
30.06.2024
Ireland Ireland
Not recruiting
30.06.2024
Italy Italy
Not recruiting
30.06.2024
Latvia Latvia
Not recruiting
30.06.2024
Lithuania Lithuania
Not recruiting
30.06.2024
Poland Poland
Not recruiting
30.06.2024
Portugal Portugal
Not recruiting
30.06.2024
Romania Romania
Not recruiting
30.06.2024
Spain Spain
Not recruiting
30.06.2024
The Netherlands The Netherlands
Not recruiting
30.06.2024

Trial locations

Investigated drugs:

Seralutinib is an investigational medication being studied for its potential to treat pulmonary arterial hypertension (PAH). It is administered through oral inhalation, which means it is breathed in through the mouth using a special device. The purpose of this study is to assess how safe and well-tolerated seralutinib is when used over a long period by people with PAH. This medication aims to help manage the symptoms of PAH and improve the quality of life for those affected by this condition.

Investigated diseases:

Pulmonary Arterial Hypertension – Pulmonary Arterial Hypertension (PAH) is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure is due to the narrowing or blockage of these small arteries, which makes it harder for blood to flow through them. As a result, the heart has to work harder to pump blood through the lungs, which can lead to symptoms such as shortness of breath, fatigue, and dizziness. Over time, the increased workload can cause the heart to become enlarged and weakened. PAH can progress gradually, with symptoms worsening as the disease advances. It is considered a rare disease and can affect individuals of any age, though it is more common in young adults.

Trial ID:
2023-506334-75-00
Protocol code:
GB002-3102
NCT ID:
NCT06274801
Trial Phase:
Therapeutic confirmatory (Phase III)

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