Építés alatt – nem éles oldal
Belépés
Még nem keres résztvevőt itt: Mexikó3. fázis

A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)

A legfontosabb adatok

Ki végzi
Boehringer Ingelheim
Hol
Chihuahua City, León, Mexico City, Monterrey, Nuevo León, Oaxaca City és Tlalnepantla (Mexikó)Mind a 7 helyszín megnézéseMég 40 másik országban, 385 helyszínen
Azonosító
Állapot
Toborzás még nem indult
Fázis
3. fázis
Résztvevők
1500 fő, tervezett
Kezdés
2027. jan. 11.
Várható befejezés
2029. szept. 10.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • verducatib
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for people aged 12 or older with bronchiectasis who finished an earlier verducatib study. All participants take verducatib tablets once a day.

Életkor
12 years and older
Nem
All sexes
A betegség stádiuma
Bronchiectasis (widened, damaged airways in the lungs).
Korábbi kezelés
Must have completed the treatment period of trial 1397-0014 (AIRTIVITY®) or 1397-0017 (CLAIRLEAF®) as planned, without stopping the trial treatment early.

A részvétel fő kizáró okai

  • Moderate or severe liver disease (Child-Pugh B or C), unless the study doctor decides joining is in the person's interest.
  • Kidney function (eGFR) below 30 mL/min, unless the study doctor decides joining is in the person's interest.
  • Neutrophil count (a type of white blood cell) below 1000/mm^3.
  • A weakened immune system (immunodeficiency) diagnosed after the earlier trial's treatment ended.
  • Needing or wanting to keep taking medicines the trial does not allow.

A regiszter feltételei, szó szerint

Mind a 11 feltétel megnézéseKevesebb

Ki vehet részt

  • Participants (adults and adolescents ≥12 years of age) who completed the treatment period in trials 1397-0014 or 1397-0017 as planned per protocol and did not discontinue trial treatment prematurely
  • Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information
  • Signed and dated written informed consent and assent, if applicable, prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation

Ki nem vehet részt

  • Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
  • Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment), unless the investigator determines it is in the best interest of the participant to enrol in the trial
  • Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study
  • Participants not expected to comply with the protocol requirements or not expected to complete the trial as scheduled, i.e. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the participant an unreliable trial participant; Further exclusion criteria apply
  • Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) and Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) <30 mL/min at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then), unless the investigator determines it is in the best interest of the participant to enrol in the trial
  • An absolute blood neutrophil count <1000/mm\^3 (equivalent to <1000 cells/µL or <10\^9 cells/L) at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then)
  • Any findings in the medical examination and/or laboratory value assessed at Visit 1 (or at the last safety assessment in the parent trial, concerning the laboratory tests, if no more than 6 weeks passed since then), that in the opinion of the investigator may put the participant at risk by participating in the trial
  • Diagnosis of primary or secondary immunodeficiency made after end of treatment in preceding trial

Helyszínek itt: Mexikó

Még 40 másik országban, 385 helyszínen

  • Centro de Investigacion Integral MEDIVEST S.CChihuahua City, MexikóContact: Boehringer IngelheimNo longer taking part
  • Mediadvance Clinical S.A.P.I de C.V.Chihuahua City, MexikóContact: Boehringer IngelheimNo longer taking part
  • Centro de Investigacion Farmacologica del Bajio, S.C.León, MexikóContact: Boehringer IngelheimNo longer taking part
  • Soluciones terapeuticas medico quirurgicas S de RL de CVMexico City, MexikóContact: Boehringer IngelheimNo longer taking part
  • Hospital Universitario Nuevo de Nuevo León - CEPREPMonterrey, Nuevo León, MexikóContact: Boehringer IngelheimNo longer taking part
  • Oaxaca Site Management Organization S.C.Oaxaca City, MexikóContact: Boehringer IngelheimNo longer taking part
  • Clinical Research Institute S.C.Tlalnepantla, MexikóContact: Boehringer IngelheimNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

This study is for adults and adolescents who are at least 12 years old and have bronchiectasis. People can participate if they completed a previous study with the study medicine called verducatib. The purpose of this study is to find out how well verducatib is tolerated when people with bronchiectasis take it for a long time. The study also looks at breathing problems, how often lung flare-ups happen, and how quickly lung function changes.

A teljes eredeti leírásKevesebb

This is a roll-over study for participants who completed a previous study with verducatib: AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017). All participants receive verducatib. Participants take verducatib as tablets once a day at home. They may continue their usual treatment for bronchiectasis during the study.

Participants can stay in the study for up to 1 year and 9 months. Treatment with verducatib can continue for up to 1 year and 6 months. About 6 study visits are done at the study site and about 4 are done by phone. At all visits, the doctors check participants' health and collect information on any health problems that occur during the study. The doctors also look at lung flare-ups and measure lung function over time.

A vizsgálat csoportja

  • Participants with bronchiectasis rolling over from parent trialsA vizsgált kezelés

    Participants with bronchiectasis who completed parent trials AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017) and did not prematurely discontinue the trial drug.

    Kezelés: verducatib

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
Hivatalos cím
An Open-label, Roll-over Study Evaluating the Long-term Safety and Efficacy of an Oral Dose of Verducatib q.d. in Patients With Bronchiectasis (AIRTIVITY®-ON)
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
A regiszteradat frissítve
2026. november 12.