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Clinical Trial of GenSci136 in Patients With Myasthenia Gravis

11. november 2026 opdateret af: Changchun GeneScience Pharmaceutical Co., Ltd.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/II Clinical Trial (Including an Open-Label Extension Phase) to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of GenSci136 for Injection in Patients With Myasthenia Gravis

Phase Ib/II Clinical Trial of GenSci136 in Patients with Myasthenia Gravis

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/II Clinical Trial (Including an Open-Label Extension Phase) to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of GenSci136 for Injection in Patients with Myasthenia Gravis

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
72

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Huashan Hospital ,Fudan University

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

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female, aged 18 to 70 years (both inclusive).
  2. standard-of-care (SoC) treatment for MG before screening.
  3. Men of reproductive age and women of childbearing potential must agree to take highly effective contraceptive methods from screening to 5 months after the last dose4. Participants who can understand the trial procedures, voluntarily participate in the trial (themselves or through their legally acceptable representative), For participants with gMG: 1. Participants diagnosed with gMG with generalized muscle weakness, corresponding to Myasthenia Gravis Foundation of America (MGFA) clinical classification Class II-IV

2. Positive for anti-AChR antibodies or anti-MuSK antibodies. 3. MG-ADL score must be ≥ 6, and the ocular score must account for < 50% of the total score. 4. QMG score must be ≥ 8, with at least 4 individual items scored ≥ 2. For participants with oMG: 1. Participants with a diagnosis of MG supported by the following medical documentation: a. Positive anti-AChR or anti-MuSK autoantibodies; or b. Abnormal neuromuscular transmission confirmed by single-fiber electromyography (SFEMG)/repetitive nerve stimulation (RNS), together with at least one of the following pharmacological/clinical confirmations: 1) documented positive ice pack test (resolution of ptosis after application of an ice pack to the eyelid for 2 minutes, with an improvement of > 2 mm); 2) documented positive edrophonium chloride (Tensilon) test, or a positive test with another cholinesterase inhibitor currently used in clinical practice to confirm oMG, such as the neostigmine test; or 3) documented improvement in MG signs following treatment with oral AChE inhibitors, plasma exchange, IVIg, glucocorticoids, or other relevant therapies. 2. Participants diagnosed with oMG, corresponding to MGFA clinical classification Class I. 3. the MGII (PRO) ocular score must be ≥ 6, and at least 2 ocular items must have a score of ≥ 2. 4. No pupillary abnormalities, except those caused by previous localized disease or surgery.

Exclusion Criteria:

  1. Known hypersensitivity to GenSci136 or any of the excipients contained in the GenSci136 formulation, or history of serious hypersensitivity reactions to any drug
  2. Participants with diseases or dysfunctions (excluding MG) known to interfere with the clinical trial,
  3. Participants with a known history of malignant tumors (including but not limited to lung cancer, colorectal cancer, liver cancer, gastric cancer, esophageal cancer, prostate cancer, thyroid cancer, bladder cancer, pancreatic cancer, kidney cancer, breast cancer, cervical cancer, corpus uteri cancer, ovarian cancer and malignant melanoma) are excluded unless they have been free of recurrence for ≥ 3 years; basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, breast carcinoma in situ, and incidental prostate cancer T1a/T1b are not excluded under this criterion (for thymoma-related requirements, see Exclusion Criterion 8).
  4. Presence of acute or chronic infections requiring treatment at screening.
  5. History of MG crisis within 1 month before screening.
  6. Diagnosis of any other autoimmune disease at screening other than MG, e.g., rheumatoid arthritis, Sjögren's syndrome (patients with abnormal thyroid function at screening will be excluded; those with autoimmune thyroiditis under stable control for ≥ 6 months and with normal thyroid function at screening may be exempted). 7. Participants who have attempted suicide within the past year or are currently at risk of impulsive behavior or suicide. 8. Participants with current or prior thymoma or thymectomy (except those meeting the criteria specified below), or planned thymectomy during the trial period. 9. Receipt of any live or live attenuated vaccine within 1 month before screening, or planned receipt of any live or live attenuated vaccine (except inactivated vaccine) during the trial period. 10. Receipt of intravenous, subcutaneous, or intramuscular immunoglobulin or plasma exchange within 1 month before screening. 11. Treatment with any form of CAR-T cell therapy, T-cell engager (TCE) therapy, or biologics targeting CD19/CD20 within 1 year before screening. 12. Positive hepatitis B virus at screening [hepatitis B surface antigen (HBsAg) positive; or HBsAg negative with hepatitis B core antibody (HBcAb) positive and hepatitis B virus deoxyribonucleic acid (HBV-DNA) positive or > upper limit of normal (ULN)], positive hepatitis C virus antibody (HCV-Ab), positive human immunodeficiency virus antibody (HIV-Ab), or positive syphilis serology test. 13. 12-lead ECG abnormalities during the screening period or at baseline, e.g., heart rate-corrected QT interval QTcF absolute value > 470 ms (Fridericia's formula: QTcF = QT/RR0.33) that, upon assessment by the investigator, may interfere with this clinical trial. 14. During the screening or baseline period, participants with any of the following abnormal laboratory test results: a) Absolute neutrophil count (ANC) < 1.2 × 10³/μL ; b) Platelet count < 75,000/μL (i.e., < 75 × 10⁹/L); c) Hemoglobin < 8.0 g/dL; d) IgG < 600 mg/dL; e) Creatinine > 1.5 × ULN or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2; f) Glycated hemoglobin (HbA1c) > 8.0%, except for participants whose blood glucose control is considered adequate by the investigator; g) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN), or total bilirubin (TBIL) > 1.5 × ULN; h) Other abnormal laboratory test results deemed by the investigator to make the participant unsuitable for participation in the study. 15. Participants judged by the investigator to be ineligible for other reasons.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: GenSci136 for injection
Medicin: GenSci136 for injection

GenSci136 for injection, administered the medication according to the requirements of the protocal
Placebo komparator: GenSci136 blank excipient(placebo) for injection
Medicin: GenSci136 for injection

GenSci136 for injection, administered the medication according to the requirements of the protocal

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Tidsramme
Changes from baseline in the incidence and severity of TEAEs/SAEs occurring within 10 weeks after the first dose and other safety measures (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG], etc.).
Tidsramme: From time of informed consent to 10 weeks after the first dose of GenSci136
From time of informed consent to 10 weeks after the first dose of GenSci136
Changes from baseline in the incidence and severity of TEAEs/SAEs occurring within 10 weeks after the first dose and other safety measures (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG], etc.).
Tidsramme: Approximately 26 weeks
Approximately 26 weeks

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
area under the concentration-time curve from time 0 to time t of the last quantifiable concentration (AUC0-t)
Tidsramme: Approximately 10 weeks.
Approximately 10 weeks.
area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Tidsramme: Approximately 10 weeks
Approximately 10 weeks
area under the concentration-time curve from time 0 to time τ (AUC0-τ)
Tidsramme: Approximately 10 weeks
Approximately 10 weeks
maximum concentration (Cmax)
Tidsramme: Approximately 10 weeks
Approximately 10 weeks
time to maximum concentration (Tmax)
Tidsramme: Approximately 10 weeks
Approximately 10 weeks
apparent clearance (CL/F)
Tidsramme: Approximately 10 weeks
Approximately 10 weeks
apparent volume of distribution (Vd/F)
Tidsramme: Approximately 10 weeks
Approximately 10 weeks
Changes from baseline in free and total A proliferation-inducing ligand (APRIL) levels
Tidsramme: Approximately 10 weeks
Approximately 10 weeks
Changes from baseline in free and total B-cell activating factor (BAFF) levels
Tidsramme: Approximately 10 weeks
Approximately 10 weeks
Change from baseline in MG-ADL score at Week 48
Tidsramme: Approximately 48 Weeks

The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is an 8-item instrument used to assess the impact of myasthenia gravis symptoms on daily activities. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 24. Higher scores indicate greater disease severity and worse functional status.
Approximately 48 Weeks
Proportion of participants with a ≥ 2-point reduction from baseline in MG-ADL score at Week 26 and Week 48
Tidsramme: Approximately 48 Weeks

The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is an 8-item instrument used to assess the impact of myasthenia gravis symptoms on daily activities. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 24. Higher scores indicate greater disease severity and worse functional status.
Approximately 48 Weeks
Proportion of participants with a ≥ 3-point reduction from baseline in QMG score at Week 26 and Week 48
Tidsramme: Approximately 48 Weeks

The Quantitative Myasthenia Gravis (QMG) score is a 13-item clinician-administered measure used to assess muscle weakness and disease severity in patients with myasthenia gravis. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 39. Higher scores indicate greater disease severity and worse clinical outcomes.
Approximately 48 Weeks
Proportion of participants with minimal symptom expression (MSE, MG-ADL score of 0 or 1) at Week 26 and Week 48
Tidsramme: Approximately 48 Weeks

Minimal symptom expression (MSE) is defined as a Myasthenia Gravis Activities of Daily Living (MG-ADL) total score of 0 or 1. The MG-ADL is an 8-item scale used to assess the impact of myasthenia gravis symptoms on daily activities. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 24, with higher scores indicating greater disease severity and worse functional status.
Approximately 48 Weeks
Change from baseline in total Myasthenia Gravis Composite (MGC) score at Week 26 and Week 4
Tidsramme: Approximately 26 Weeks

The Myasthenia Gravis Composite (MGC) is a validated 10-item assessment tool used to evaluate the clinical severity of myasthenia gravis, incorporating both physician-assessed and patient-reported measures. The total score ranges from 0 to 50, with higher scores indicating greater disease severity and worse clinical outcomes
Approximately 26 Weeks
Change from baseline in Revised Myasthenia Gravis Quality of Life-15 (MG-QoL15r) score at Week 26 and Week 48
Tidsramme: Approximately 48 Weeks

The Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) is a patient-reported questionnaire used to assess the impact of myasthenia gravis on health-related quality of life. It consists of 15 items, each scored from 0 to 2, resulting in a total score ranging from 0 to 30. Higher scores indicate greater impairment in quality of life and worse clinical outcomes.
Approximately 48 Weeks
Change from baseline in EuroQol Five-Dimension Five-Level (EQ-5D-5L) score at Week 26 and Week 48
Tidsramme: Approximately 48 Weeks

The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire is a standardized measure of health-related quality of life comprising five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from 1 (no problems) to 5 (extreme problems). Responses are converted into a health utility index. The EQ Visual Analogue Scale (EQ-VAS) assesses participants' self-rated overall health status on a scale from 0 (worst imaginable health) to 100 (best imaginable health). Higher Index and EQ-VAS scores indicate better health status.
Approximately 48 Weeks
Change from baseline in MG-ADL score over time
Tidsramme: Approximately 48 Weeks

The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is an 8-item instrument used to assess the impact of myasthenia gravis symptoms on daily activities. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 24. Higher scores indicate greater disease severity and worse functional status.
Approximately 48 Weeks
Change from baseline in QMG score over time
Tidsramme: Approximately 48 Weeks

The Quantitative Myasthenia Gravis (QMG) score is a 13-item clinician-administered measure used to assess muscle weakness and disease severity in patients with myasthenia gravis. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 39. Higher scores indicate greater disease severity and worse clinical outcomes.
Approximately 48 Weeks
Change from baseline in MGC score over time
Tidsramme: Approximately 48 Weeks

The Myasthenia Gravis Composite (MGC) is a validated 10-item assessment tool used to evaluate the clinical severity of myasthenia gravis, incorporating both physician-assessed and patient-reported measures. The total score ranges from 0 to 50, with higher scores indicating greater disease severity and worse clinical outcomes.
Approximately 48 Weeks
Change from baseline in MG-QoL15r score over time
Tidsramme: Approximately 48 Weeks

The Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) is a patient-reported questionnaire used to assess the impact of myasthenia gravis on health-related quality of life. It consists of 15 items, each scored from 0 to 2, resulting in a total score ranging from 0 to 30. Higher scores indicate greater impairment in quality of life and worse clinical outcomes.
Approximately 48 Weeks
Change from baseline in EQ-5D-5L score over time
Tidsramme: Approximately 48 Weeks

The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire is a standardized measure of health-related quality of life comprising five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from 1 (no problems) to 5 (extreme problems). Responses are converted into a health utility index. The EQ Visual Analogue Scale (EQ-VAS) assesses participants' self-rated overall health status on a scale from 0 (worst imaginable health) to 100 (best imaginable health). Higher Index and EQ-VAS scores indicate better health status.
Approximately 48 Weeks
Change from baseline in ocular score of the Myasthenia Gravis Impairment Index (participant-reported outcomes) [MGII (PRO)] at Week 26 and Week 48
Tidsramme: Approximately 48 weeks

The Myasthenia Gravis Impairment Index (MGII) is a validated measure of myasthenia gravis disease severity comprising 22 patient-reported outcome (PRO) items and 6 physical examination (PE) items. The MGII ocular PRO score consists of 6 patient-reported items assessing the frequency, severity, and impact of diplopia and ptosis. Each item is scored from 0 to 3, yielding a total ocular PRO score ranging from 0 to 18. Higher scores indicate more severe ocular symptoms.
Approximately 48 weeks
Change from baseline in ocular score of the Myasthenia Gravis Impairment Index (Participant-reported Outcome and Physical Examination) (MGII [PRO+PE]) at Week 26 and Week 48
Tidsramme: Approximately 48 weeks

The Myasthenia Gravis Impairment Index (MGII) is a validated measure of myasthenia gravis disease severity comprising 22 patient-reported outcome (PRO) items and 6 physical examination (PE) items. The MGII ocular PRO+PE score combines 6 patient-reported items and 2 clinician-assessed physical examination items evaluating diplopia and ptosis. The score is calculated as the sum of these 8 items, ranging from 0 to 23. Higher scores indicate more severe ocular impairment
Approximately 48 weeks
Change from baseline in ocular score of the MGII (PE) at Week 26 and Week 48
Tidsramme: Approximately 48 weeks

The Myasthenia Gravis Impairment Index (MGII) is a validated measure of myasthenia gravis disease severity comprising patient-reported and physical examination components. The MGII ocular physical examination (PE) score consists of 2 clinician-assessed items evaluating diplopia (scored from 0 to 3) and ptosis (scored from 0 to 2). The total ocular PE score ranges from 0 to 5, with higher scores indicating more severe ocular impairment.
Approximately 48 weeks
Changes from baseline in total MGII score at Week 26 and Week 48
Tidsramme: Approximately 48 weeks
Approximately 48 weeks
Changes from baseline in the incidence and severity of TEAEs
Tidsramme: Approximately 64 weeks

The Myasthenia Gravis Impairment Index (MGII) is a validated measure of myasthenia gravis disease severity comprising 28 items, including 22 patient-reported outcome (PRO) items and 6 physical examination (PE) items. The MGII evaluates ocular and generalized impairments, including symptoms affecting ocular, bulbar, respiratory, and limb muscle function. The total score is calculated as the sum of all 28 items and ranges from 0 to 84. Higher scores indicate greater disease severity and impairment.
Approximately 64 weeks
Changes from baseline in the incidence and severity of SAEs
Tidsramme: Approximately 64 weeks
Approximately 64 weeks
steady-state maximum concentration (Cmax, ss)
Tidsramme: Approximately 64 weeks
Approximately 64 weeks
steady-state trough concentration (Cmin, ss)
Tidsramme: Approximately 64 weeks
Approximately 64 weeks
time to steady-state maximum concentration (Tmax, ss)
Tidsramme: Approximately 64 weeks
Approximately 64 weeks
mean concentration at steady state (Cav, ss)
Tidsramme: Approximately 64 weeks
Approximately 64 weeks
area under the concentration-time curve over the dosing interval at steady state (AUC0-τ, ss)
Tidsramme: Approximately 64 weeks
Approximately 64 weeks
Changes from baseline in free and total APRIL levels
Tidsramme: Approximately 64 weeks
Approximately 64 weeks
Changes from baseline in free and total BAFF levels
Tidsramme: Approximately 64 weeks
Approximately 64 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Changchun GeneScience Pharmaceutical Co., Ltd.

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Sushan Luo, Huashan Hospital
  • Ledende efterforsker: Bitao Bu, Tongji Hospital

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 (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. december 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. december 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. juni 2029

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
27. oktober 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
11. november 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
13. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
11. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • GenSci136-201

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

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 .

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