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Die klinische Studie NCT06738485 für Congenital Hemophilia A ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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CSLRecombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products Phase 3 60
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Die klinische Studie NCT06738485 untersucht Prävention im Zusammenhang mit Congenital Hemophilia A. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 9. Januar 2025. Es ist geplant, 60 Teilnehmer aufzunehmen. Durchgeführt von CSL wird der Abschluss für 26. Juni 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 8. Januar 2026 aktualisiert.
Kurzbeschreibung
For bridging the available global clinical data of rVIII-SingleChain, with the Chinese population, the aim of this study in China is to investigate the pharmacokinetics (PK) of rVIII-SingleChain after an initial and repeat dose and to assess efficacy and safety during 2 to 3 times weekly prophylaxis treatment with rVIII-SingleChain in male Chinese PTPs with severe hemophilia A (FVIII activity less than \[\<\] 1%).
Offizieller Titel
A Phase 3, Open-label, Multicenter, Pharmacokinetics, Efficacy, and Safety Study of a Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Previously Treated Patients (PTPs) With Hemophilia A
Erkrankungen
Congenital Hemophilia AWeitere Studien-IDs
- CSL627_3003
- 2023-001026-34 (EudraCT-Nummer)
NCT-Nummer
Studienbeginn (tatsächlich)
2025-01-09
Zuletzt aktualisiert
2026-01-08
Studienende (vorauss.)
2026-06-26
Geplante Rekrutierung
60
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Primäres Ziel
Prävention
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellrVIII-SingleChain Participants will receive rVIII-SingleChain as an intravenous (IV) infusion for a minimum of 50 exposure days (EDs). | Recombinant single-chain factor VIII (rVIII-SingleChain) Lyophilized powder for solution for intravenous injection |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Incremental Recovery (IR) of rVIII-SingleChain | Before, and at 30 minutes after the end of, rVIII-SingleChain administration on Day 1 | |
Maximum Concentration (Cmax) of rVIII-SingleChain | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 | |
Area Under the Plasma Concentration Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of rVIII-SingleChain | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 | |
Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUC0-inf) of rVIII-SingleChain | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 | |
Half-life (t1/2) of rVIII-SingleChain | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 | |
Clearance (Cl) of rVIII-SingleChain | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 | |
Annualized Spontaneous Bleeding Rate (AsBR) | AsBR for treated bleeding episodes | Up to 29 weeks after rVIII-SingleChain administration |
Number of participants who develop FVIII inhibitors | During routine rVIII-SingleChain prophylaxis dosing, up to 29 weeks after rVIII-SingleChain administration. |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Time to reach maximum concentration (Tmax) of rVIII-SingleChain | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 | |
Last Concentration (Clast) of rVIII-SingleChain | Last observed quantifiable plasma concentration | Before, and up to 72 hours (participants ≥ 12 years ) and 48 hours (participants < 12 years) after rVIII-SingleChain administration on Day 1 |
IR (participants ≥ 12 years of age) of rVIII-SingleChain (Repeat pharmacokinetic [PK]) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
Cmax (participants ≥ 12 years of age) of rVIII-SingleChain (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
AUC0-last of rVIII-SingleChain (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
AUC0-inf of rVIII-SingleChain (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
t1/2 of rVIII-SingleChain (participants ≥ 12 years of age) (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
Cl of rVIII-SingleChain (participants ≥ 12 years of age) (Repeat PK) | Before, and at up to 72 hours after the end of, rVIII-SingleChain infusion at Week 28 | |
Annualized Bleeding Rate (ABR) | Total ABR for treated, untreated, and both treated and untreated bleeding episodes (spontaneous, traumatic, and unknown cause) | Up to 29 weeks after rVIII-SingleChain administration |
Hemostatic Efficacy for Major and Nonmajor Bleeding Episodes | The investigator will rate the efficacy of the rVIII-SingleChain treatment for major and nonmajor bleeding episodes based on a hemostatic efficacy four point rating scale of "excellent, good, moderate or no efficacy". | Up to 29 weeks after rVIII-SingleChain administration |
Consumption of rVIII-SingleChain - number of infusions (doses) | Up to 29 weeks after rVIII-SingleChain administration | |
Consumption of rVIII-SingleChain - IU/kg per participant per month | rVIII-SingleChain consumption (IU/kg) per participant per month, for the weekly regimen, on-demand treatment, and total treatment. | Up to 29 weeks after rVIII-SingleChain administration |
Consumption of rVIII-SingleChain - IU/kg per participant per year | rVIII-SingleChain consumption (IU/kg) per participant per year, for the weekly regimen, on-demand treatment, and total treatment. | Up to 29 weeks after rVIII-SingleChain administration |
Number of bleeding episodes requiring rVIII-SingleChain to achieve hemostasis | Number of bleeding episodes requiring 1, \<= 2, or \> 2 infusions (doses) of rVIII-SingleChain to achieve hemostasis | Up to 29 weeks after rVIII-SingleChain administration |
Percentage of bleeding episodes requiring rVIII-SingleChain to achieve hemostasis | Percentage of bleeding episodes requiring 1, \<= 2, or \> 2 infusions (doses) of rVIII-SingleChain to achieve hemostasis | Up to 29 weeks after rVIII-SingleChain administration |
Number of participants who develop noninhibitory antibodies against rVIII-SingleChain | Before, and up to 29 weeks after, rVIII-SingleChain administration | |
Number of participants who develop antibodies against Chinese hamster ovary host cell protein | Before, and up to 29 weeks after, rVIII-SingleChain administration | |
Number of participants with Treatment-emergent Adverse Events (TEAEs), including related TEAEs, and serious adverse events (SAEs) | Up to 33 weeks after rVIII-SingleChain administration | |
Percentage of participants with TEAEs, including related TEAEs, and serious adverse events (SAEs) | Up to 33 weeks after rVIII-SingleChain administration | |
Number of TEAEs (events) | Up to 33 weeks after rVIII-SingleChain administration |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
0 Days
Zugelassene Geschlechter
Männlich
- • Male Chinese participants <= 65 years of age.
- • Participants with severe hemophilia A (FVIII activity < 1%).
- • Participants who have received FVIII products for >= 150 EDs (>= 6 years of age) or >= 50 EDs (< 6 years of age).
- • Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
- • Known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
- • Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
- • Receiving any cryoprecipitate, whole blood, or plasma within 30 days before administration of rVIII-SingleChain.
- • Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia, including coagulation, within 28 days before Day 1 and / or refusal to abstain from these during the study until the end of the participant's participation in the study.
CSLZentrale Studienkontakte
Kontakt: Trial Registration Coordinator, +1-610-878-4000, [email protected]
20 Studienstandorte in 1 Ländern
Anhui
The Second Hospital of Anhui Medical University, Hefei, Anhui, 230000, China
Study Coordinator, Kontakt, +86 18860473785
Offene Rekrutierung
Beijing Municipality
Beijing Children's Hospital, Beijing, Beijing Municipality, 100045, China
Study Coordinator, Kontakt, +86 19967242842
Offene Rekrutierung
Chongqing Municipality
Children's Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400014, China
Offene Rekrutierung
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Study Coordinator, Kontakt, +86-13960923029
Offene Rekrutierung
Guangdong
Guangzhou Women and Children's Medical Center, Guangzhou, Guangdong, 510623, China
Study Coordinator, Kontakt, +86 14714147022
Offene Rekrutierung
Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, 515399, China
Study Coordinator, Kontakt, +86 13407467308
Offene Rekrutierung
Guangxi
Liuzhou People's Hospital, Liuchow, Guangxi, 545006, China
Study Coordinator, Kontakt, + 86 18775236492
Offene Rekrutierung
Hebei
North China University of Science and Technology Affiliated Hospital, Tangshan, Hebei, 63000, China
Study Coordinator, Kontakt, +86 13596672024
Offene Rekrutierung
Hospital of Hematology, Chinese Academy of Medical Sciences, Tianjin, Hebei, 300020, China
Study Coordinator, Kontakt, +86 15002287107
Offene Rekrutierung
Henan
Henan children's hospital Zhengzhou children's Hospital, Zhengzhou, Henan, 450053, China
Offene Rekrutierung
Hunan
Hunan Provincial Children's Hospital, Changsha, Hunan, 410021, China
Study Coordinator, Kontakt, +86 19138294667
Offene Rekrutierung
Jiangsu
Nanjing Children's Hospital, Nanjing, Jiangsu, 210008, China
Offene Rekrutierung
XuZhou Children's Hospital, Xuzhou, Jiangsu, 221006, China
Study Coordinator, Kontakt, +86 15062104467
Offene Rekrutierung
Jiangxi
Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, 212028, China
Study Coordinator, Kontakt, +86 13879403212
Offene Rekrutierung
Qinghai
Quinghai Provincial People's Hospital, Xining, Qinghai, 81000, China
Study Coordinator, Kontakt, +86 18795981099
Offene Rekrutierung
Shandong
Jinan Central Hospital, Jinan, Shandong, 250013, China
Offene Rekrutierung
Qingdao Women and Children's Hospital, Qingdao, Shandong, 266071, China
Study Coordinator, Kontakt, +86 13156850390
Offene Rekrutierung
Shanghai Municipality
Shanghai Jiaotong University School of Medicine, Ruijin Hospital, Shanghai, Shanghai Municipality, 200020, China
Study Coordinator, Kontakt, +86 17621778635
Offene Rekrutierung
Yunan
The second affiliated hospital of Kunming Medical University, Kunming, Yunan, 650011, China
Study Coordinator, Kontakt, +86 18287102704
Offene Rekrutierung
Zhejiang
The Children's Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310005, China
Study Coordinator, Kontakt, +86 17621778635
Offene Rekrutierung