Langsigtet vurdering af sikkerhed og effekt af subkutan amlitelimab hos voksne deltagere med moderat til svær astma, som afsluttede behandlingsperioden for tidligere amlitelimab astma klinisk undersøgelse (RIVER-ASTHMA)
29. september 2026 opdateret af: Sanofi
En langsigtet forlængelsesundersøgelse til evaluering af den langsigtede sikkerhed, tolerabilitet og effektivitet af subkutan amlitelimab hos voksne deltagere med moderat til svær astma, der fuldførte behandlingsperiode for tidligere amlitelimab astma klinisk undersøgelse
This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
The duration of the study for each participant will be up to 156 weeks.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
335
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, 1425
- Investigational Site Number : 0320001
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Buenos Aires, Argentina, 1121
- Investigational Site Number : 0320004
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Buenos Aires, Argentina, 1414
- Investigational Site Number : 0320003
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Buenos Aires, Argentina, 1425
- Investigational Site Number : 0320002
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Buenos Aires, Argentina, 1650
- Investigational Site Number : 0320009
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Buenos Aires
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La Plata, Buenos Aires, Argentina, 1900
- Investigational Site Number : 0320008
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320006
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320007
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320005
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São Paulo, Brasilien, 05403-000
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
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Espírito Santo
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Vitória, Espírito Santo, Brasilien, 29055-450
- Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilien, 40060-330
- Associacao Proar- Site Number : 0760004
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Rio Grande do Sul
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Passo Fundo, Rio Grande do Sul, Brasilien, 99010-170
- Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001
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Porto Alegre, Rio Grande do Sul, Brasilien, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007
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Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
- Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006
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São Paulo
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Sorocaba, São Paulo, Brasilien, 18040-425
- Clinica de Alergia Martti Antila- Site Number : 0760003
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Ontario
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Ottawa, Ontario, Canada, K1G 6C6
- Investigational Site Number : 1240008
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Quebec
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Trois-Rivières, Quebec, Canada, G8T 7A1
- Investigational Site Number : 1240007
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Maule Region
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Talca, Maule Region, Chile, 3465584
- Investigational Site Number : 1520006
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Chile, 7500692
- Investigational Site Number : 1520001
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Santiago, Reg Metropolitana de Santiago, Chile, 7750495
- Investigational Site Number : 1520003
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Santiago, Reg Metropolitana de Santiago, Chile, 8380465
- Investigational Site Number : 1520008
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Valparaiso
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Quillota, Valparaiso, Chile, 2260877
- Investigational Site Number : 1520005
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Bradford, Det Forenede Kongerige, BD9 6RJ
- Investigational Site Number : 8260001
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California
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Stockton, California, Forenede Stater, 95207
- Bensch Research Associates- Site Number : 8400004
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Florida
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Boynton Beach, Florida, Forenede Stater, 33435
- Helix Biomedics- Site Number : 8400029
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Miami Lakes, Florida, Forenede Stater, 33014
- Savin Medical Group - Miami Lakes- Site Number : 8400015
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Pembroke Pines, Florida, Forenede Stater, 33025
- Pines Care Research Center- Site Number : 8400028
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- Treasure Valley Medical Research- Site Number : 8400031
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Johns Hopkins Bayview Medical Center- Site Number : 8400012
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Oklahoma
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Edmond, Oklahoma, Forenede Stater, 73034
- OK Clinical Research- Site Number : 8400001
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Texas
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Boerne, Texas, Forenede Stater, 78006
- South Texas Medical Research Institute - TTS Research- Site Number : 8400011
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Verona, Italien, 37134
- Investigational Site Number : 3800001
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Napoli
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Naples, Napoli, Italien, 80131
- Investigational Site Number : 3800004
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Roma
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Rome, Roma, Italien, 00168
- Investigational Site Number : 3800003
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Hiroshima, Japan, 732-0052
- Investigational Site Number : 3920019
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Tokyo, Japan, 140-8522
- Investigational Site Number : 3920001
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Tokyo, Japan, 103-0027
- Investigational Site Number : 3920005
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Osaka
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Sakai, Osaka, Japan, 591-8555
- Investigational Site Number : 3920010
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Tokyo
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Chūō, Tokyo, Japan, 104-0031
- Investigational Site Number : 3920004
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Chihuahua City, Mexico, 31000
- Investigational Site Number : 4840002
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Jalisco
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Guadalajara, Jalisco, Mexico, 44100
- Investigational Site Number : 4840001
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Guadalajara, Jalisco, Mexico, 44670
- Investigational Site Number : 4840005
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Yucatán
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Mérida, Yucatán, Mexico, 97070
- Investigational Site Number : 4840008
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Elblag, Polen, 82-300
- Investigational Site Number : 6160003
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 60-693
- Investigational Site Number : 6160001
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 31-209
- Investigational Site Number : 6160006
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Tarnów, Lesser Poland Voivodeship, Polen, 33-100
- Investigational Site Number : 6160007
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polen, 15-044
- Investigational Site Number : 6160004
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80-405
- Investigational Site Number : 6160002
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Benoni, Sydafrika, 1500
- Investigational Site Number : 7100007
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Cape Town, Sydafrika, 7530
- Investigational Site Number : 7100002
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Cape Town, Sydafrika, 7700
- Investigational Site Number : 7100001
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Middelburg, Sydafrika, 1055
- Investigational Site Number : 7100004
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Gyeongsangbuk-do
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Daegu, Gyeongsangbuk-do, Sydkorea, 42415
- Investigational Site Number : 4100004
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Seoul-teukbyeolsi
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Seoul, Seoul-teukbyeolsi, Sydkorea, 05505
- Investigational Site Number : 4100002
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Seoul, Seoul-teukbyeolsi, Sydkorea, 03722
- Investigational Site Number : 4100001
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Seoul, Seoul-teukbyeolsi, Sydkorea, 05030
- Investigational Site Number : 4100005
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Seoul, Seoul-teukbyeolsi, Sydkorea, 06591
- Investigational Site Number : 4100006
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Istanbul, Tyrkiet (Türkiye), 34098
- Investigational Site Number : 7920001
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Izmir, Tyrkiet (Türkiye), 35100
- Investigational Site Number : 7920003
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Kayseri, Tyrkiet (Türkiye), 38039
- Investigational Site Number : 7920008
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Mersin, Tyrkiet (Türkiye), 33070
- Investigational Site Number : 7920002
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İzmit, Tyrkiet (Türkiye), 41001
- Investigational Site Number : 7920005
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Edelény, Ungarn, 3780
- Investigational Site Number : 3480009
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Gödöllő, Ungarn, 2100
- Investigational Site Number : 3480011
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Püspökladány, Ungarn, 4150
- Investigational Site Number : 3480006
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Százhalombatta, Ungarn, 2440
- Investigational Site Number : 3480012
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol
- Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated Note for Japan: participants must be on ≥400 μg of fluticasone propionate daily or equivalent.
- Contraception for male and female participants;
For female participants:
- incapable of becoming pregnant
- not pregnant or breast feeding
- not to donate or cryopreserve eggs for female participants For male participants
- No sperm donation or cryopreserving sperms
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Chronic lung disease other than asthma
- Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation
- Current smoker or active vaping of any products and/or marijuana smoking
- Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Treatment group 1
Subcutaneous Injection as per protocol |
Injection Solution: by subcutaneous injection (SCI) |
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Eksperimentel: Treatment group 2
Subcutaneous injection as per protocol |
Injection Solution: by subcutaneous injection (SCI) |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of participants with treatment-emergent adverse events
Tidsramme: From baseline up to Week 156 (EOS of LTS17510)
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Percentage of participants with treatment emergent Adverse Events. |
From baseline up to Week 156 (EOS of LTS17510)
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring fra forældreundersøgelsens baseline i præbronkodilatator (BD) og post-BD forceret eksspiratorisk volumen på 1 sekund (FEV1) ved hvert spirometriendepunkt
Tidsramme: Fra basislinje for forældreundersøgelse op til uge 144 (EOT af LTS17510)
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Fra basislinje for forældreundersøgelse op til uge 144 (EOT af LTS17510)
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|
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Ændring fra LTS17510-undersøgelsens baseline i præbronkodilatator (BD) og post-BD forceret ekspiratorisk volumen på 1 sekund (FEV1) ved hvert spirometriendepunkt
Tidsramme: Fra baseline af LTS17510-undersøgelse op til uge 144 (EOT af LTS17510)
|
Fra baseline af LTS17510-undersøgelse op til uge 144 (EOT af LTS17510)
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|
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Ændring fra forældreundersøgelsens baseline i præ-BD og post-BD peak ekspiratorisk flow [PEF] ved hvert spirometriendepunkt
Tidsramme: Fra basislinje for forældreundersøgelse op til uge 144 (EOT af LTS17510)
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Fra basislinje for forældreundersøgelse op til uge 144 (EOT af LTS17510)
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Ændring fra LTS17510-undersøgelsens baseline i præ-BD og post-BD peak ekspiratorisk flow [PEF] ved hvert spirometriendepunkt
Tidsramme: Fra baseline af LTS17510-undersøgelse op til uge 144 (EOT af LTS17510)
|
Fra baseline af LTS17510-undersøgelse op til uge 144 (EOT af LTS17510)
|
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Ændring fra forældreundersøgelsens baseline i præ-BD og post-BD forceret vitalkapacitet [FVC] ved hvert spirometriendepunkt
Tidsramme: Fra basislinje for forældreundersøgelse op til uge 144 (EOT af LTS17510)
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Fra basislinje for forældreundersøgelse op til uge 144 (EOT af LTS17510)
|
|
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Ændring fra LTS17510-undersøgelsens baseline i præ-BD og post-BD forceret vitalkapacitet [FVC] ved hvert spirometriendepunkt
Tidsramme: Fra baseline af lTS17510-undersøgelsen op til uge 144 (EOT af LTS17510)
|
Fra baseline af lTS17510-undersøgelsen op til uge 144 (EOT af LTS17510)
|
|
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Ændring fra forældreundersøgelsens baseline i præ-BD og post-BD forceret ekspiratorisk flow [FEF] 25 % til 75 %) ved hvert spirometri-endepunkt
Tidsramme: Fra basislinje for forældreundersøgelse op til uge 144 (EOT af LTS17510)
|
Fra basislinje for forældreundersøgelse op til uge 144 (EOT af LTS17510)
|
|
|
Ændring fra LTS17510-undersøgelsens baseline i præ-BD og post-BD forceret ekspiratorisk flow [FEF] 25 % til 75 %) ved hvert spirometriendepunkt
Tidsramme: Fra baseline af LTS17510-undersøgelse op til uge 144 (EOT af LTS17510)
|
Fra baseline af LTS17510-undersøgelse op til uge 144 (EOT af LTS17510)
|
|
|
Ændring fra forældreundersøgelsens baseline i fraktioneret udåndet nitrogenoxid (FeNO)
Tidsramme: Fra forældreundersøgelsens baseline op til uge 144 (EOT af LTS17510)
|
Fra forældreundersøgelsens baseline op til uge 144 (EOT af LTS17510)
|
|
|
Ændring fra LTS17510-undersøgelsens baseline i fraktioneret udåndet nitrogenoxid (FeNO)
Tidsramme: Fra LTS17510-undersøgelsens baseline op til uge 144 (EOT af LTS17510)
|
Fra LTS17510-undersøgelsens baseline op til uge 144 (EOT af LTS17510)
|
|
|
Serum amlitelimab koncentrationer
Tidsramme: Fra baseline op til uge 156 (EOS af LTS17510)
|
Fra baseline op til uge 156 (EOS af LTS17510)
|
|
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Forekomst af anti-amlitelimab antistof positiv respons
Tidsramme: Fra baseline op til uge 156 (EOS af LTS17510)
|
Fra baseline op til uge 156 (EOS af LTS17510)
|
|
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Tid til første eksacerbationshændelse fra LTS17510-undersøgelsens baseline
Tidsramme: Fra baseline af LTS17510-undersøgelsen op til uge 144 (EOT af LTS17510)
|
Fra baseline af LTS17510-undersøgelsen op til uge 144 (EOT af LTS17510)
|
|
|
Percentage of participants who experienced adverse events.
Tidsramme: From baseline up to Week 156 (End of Study [EOS] of LTS17510)
|
Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs). |
From baseline up to Week 156 (End of Study [EOS] of LTS17510)
|
|
Annualized rate of severe exacerbation events over treatment period from parent study baseline
Tidsramme: From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)
|
Severe exacerbation events over treatment period from parent study baseline are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. |
From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)
|
|
Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline
Tidsramme: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
|
Severe exacerbation events over treatment period from LTS17510 study baseline defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. |
From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
|
|
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline
Tidsramme: From baseline of the parent study up to Week 144 (EOT of LTS17510)
|
Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. |
From baseline of the parent study up to Week 144 (EOT of LTS17510)
|
|
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline
Tidsramme: From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510)
|
Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. |
From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510)
|
|
Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
Tidsramme: From parent study baseline up to Week 144 (EOT of LTS17510)
|
The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled). |
From parent study baseline up to Week 144 (EOT of LTS17510)
|
|
Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
Tidsramme: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
|
The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled). |
From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
|
|
Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
Tidsramme: From baseline up to Weeks 144 (EOT of LTS17510)
|
The AQLQ(S) was designed as a self-administered participant reported outcome to measure the functional impairments that are most troublesome to adolescents and adults ≥12 years of age as a result of their asthma over the past two weeks. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7. |
From baseline up to Weeks 144 (EOT of LTS17510)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Clinical Sciences & Operations, Sanofi
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
5. september 2023
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
22. september 2026
Studieafslutning (Faktiske)
Studieafslutning
22. september 2026
Datoer for studieregistrering
Først indsendt
Først indsendt
5. september 2023
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
5. september 2023
Først opslået (Faktiske)
Først opslået
13. september 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
2. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. september 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- LTS17510
- U1111-1280-5321 (Registry Identifier: ICTRP)
- 2023-503385-24 (Registry Identifier: CTIS)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .