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0 Diseases |  |
2 Trials |
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2 Trials |  |
2 News |  |
- Ancain (omfiloctocog alfa) / Sinocelltech
Stability of Omfiloctocog alfa (SCT800) for Continuous Infusion in Hemophilia A Treatment (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_1747;
1). A patient undergoing continuous infusion post-surgery had the diluted SCT800 solution syringe changed every 6 hours, maintaining steady FVIII levels as depicted in Figure 2.
- Ancain (omfiloctocog alfa) / Sinocelltech
The lower double negative T cells proportion predicted the better high-titer inhibitors eradication outcomes of immune tolerance induction (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_1177;
A patient undergoing continuous infusion post-surgery had the diluted SCT800 solution syringe changed every 6 hours, maintaining steady FVIII levels as depicted in Figure 2. From January 2022 to September 2023, a prospective single-center cohort study was conducted on SHA children age ?8 years, with peak historical inhibitor-titer 5
- Ancain (omfiloctocog alfa) / Sinocelltech
Evaluation of Omfiloctocog alfa (SCT800) Efficacy in Real-World Treatment of Severe Hemophilia A in China: Insights from the SURPASS Study (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_891;
Before SCT800, 45.7% of patients received on-demand therapy, while the remainder had irregular or low-dose prophylaxis. Post-switch, all patients were prescribed SCT800 regular prophylaxis.
- Ancain (omfiloctocog alfa) / Sinocelltech
Trial initiation date: ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor (clinicaltrials.gov) - Jan 12, 2024
P4, N=50, Recruiting, Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Post-switch, all patients were prescribed SCT800 regular prophylaxis. Initiation date: Aug 2023 --> Nov 2023
- Ancain (omfiloctocog alfa) / Sinocelltech
Enrollment open: ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor (clinicaltrials.gov) - Jun 22, 2023
P4, N=50, Recruiting, Sponsor: Institute of Hematology & Blood Diseases Hospital
Initiation date: Aug 2023 --> Nov 2023 Not yet recruiting --> Recruiting
- | Ancain (omfiloctocog alfa) / Sinocelltech
New P4 trial: ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor (clinicaltrials.gov) - Jun 5, 2023
P4, N=50, Not yet recruiting, Sponsor: Institute of Hematology & Blood Diseases Hospital
- Ancain (omfiloctocog alfa) / Sinocelltech
LOME PILOT STUDY: A MULTICENTER CONTROLLED RANDOMIZED CLINICAL TRIAL OF LOW- VERSUS INTERMEDIATE-DOSE IMMUNE TOLERANCE INDUCTION WITH RECOMBINANT FACTOR VIII (OMFILOCTOCOG ALFA, SCT800) IN CHINA (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_2011;
The comparison of ITI success/partial success rates between MD-ITI and LD-ITI groups required longer ITI treatment time to evaluate. Hemophilia A
- Ancain (omfiloctocog alfa) / Sinocelltech
A SINGLE-CENTER, RETROSPECTIVE, OBSERVATIONAL STUDY OF THE FIRST CHINESE RFVIII (SCT800, OMFILOCTOCOG ALFA) IN REAL-WORLD PRACTICE () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_436;
Treatment options for HA have never been better with the approval of these new recombinant FVIII products that are affordable and safe. Additional factor products still in development will add to the choices that we will have in the treatment of HA patients.
- Ancain (omfiloctocog alfa) / Sinocelltech
DESIGN OF A RANDOMIZED, CONTROLLED TRIAL OF CONTINUOUS VERSUS BOLUS INFUSIONS UNDER PREOPERATIVE PHARMACOKINETIC-GUIDED BY RECOMBINANT HUMAN COAGULATION FACTOR VIII (OMFILOCTOCOG ALFA, SCT800) IN HAEMOPHILIA A () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_370;
Additional factor products still in development will add to the choices that we will have in the treatment of HA patients. N/A
- Ancain (omfiloctocog alfa) / Sinocelltech
PHASED ANALYSIS OF LOME: A RANDOMIZED TRIAL OF LOW- VERSUS INTERMEDIATE-DOSE IMMUNE TOLERANCE INDUCTION WITH RECOMBINANT FACTOR VIII (OMFILOCTOCOG ALFA, SCT800) IN CHINA () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_366;
Because of relatively short duration of ITI, we couldn't compare the success rate between LD group and MD group now. The study is ongoing.
- Ancain (omfiloctocog alfa) / Sinocelltech
EFFICACY AND SAFETY EVALUATION OF RECOMBINANT HUMAN COAGULATION FACTOR VIII (OMFILOCTOCOG ALFA, SCT800) DURING ORTHOPEDIC PROCEDURES IN SEVERE HEMOPHILIA A PATIENTS: A SINGLE CENTER RETROSPECTIVE STUDY () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_322;
The study is ongoing. The data indicate that SCT800 is effective and with a favorable safety profile for perioperative management of orthopedic procedures in patients Hemophilia A.
- Ancain (omfiloctocog alfa) / Sinocelltech
BASELINE ANALYSIS OF SURPASS STUDY, A PROSPECTIVE, NON-INTERVENTIONAL, MULTI-CENTER STUDY ON REAL-WORLD EFFECTIVENESS AND USAGE OF RECOMBINANT FACTOR VIII (SCT800, OMFILOCTOCOG ALFA) IN HEMOPHILIA A () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_316;
There were many patients switching from pdFVIII and beginning prophylaxis treatment. The majority of patients initiated SCT800 on a regimen three times a week or QoD, which may indicate that adolescent and adult patients still had a strong willingness to get better outcomes.
- || Ancain (omfiloctocog alfa) / Sinocelltech
PK/PD data, Journal: Efficacy, safety and pharmacokinetics of recombinant human coagulation factor VIII (omfiloctocog alfa) in previously treated Chinese children with severe hemophilia A. (Pubmed Central) - Nov 16, 2022
The majority of patients initiated SCT800 on a regimen three times a week or QoD, which may indicate that adolescent and adult patients still had a strong willingness to get better outcomes. Omfiloctocog alfa was efficacious and well tolerated for the prevention and treatment of bleeding in Chinese pediatric PTPs with severe hemophilia A.
- Ancain (omfiloctocog alfa) / Sinocelltech
Protocol and Primary Analysis of Lome: A Randomized Trial of Low- Versus Intermediate-Dose Immune Tolerance Induction with Recombinant Factor VIII (Omfiloctocog alfa, SCT800) in China (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_3891;
The study is ongoing and, currently, 10/40 (25%, in Part A) PwHI from 4 HTCs have been included. LOME study is the first, multicenter, prospective, randomized trial of LD vs MD ITI with domestic rFVIII (Omfiloctocog alfa, SCT800) in Chinese PwHI.
- Ancain (omfiloctocog alfa) / Sinocelltech
LONG TERM SAFETY AND EFFICACY OF RECOMBINANT HUMAN COAGULATION FACTOR VIII (SCT800) IN PREVIOUSLY TREATED PATIENTS WITH SEVERE HEMOPHILIA A () - May 13, 2022 - Abstract #EHA2022EHA_1095;
P3, P4
Improved joint function was observed in 67 patients with a mean total HJHS scores decreased by 3.4. Conclusion The interim data demonstrate favorable long-term safety of SCT800 and the maintenance of low ABR in patients with severe hemophilia A.
- Ancain (omfiloctocog alfa) / Sinocelltech
Efficacy, Safety and Pharmacokinetics of Recombinant Human Coagulation Factor VIII (SCT800) in Previously Treated Children with Severe Hemophilia A. (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1161;
The median ABRs of the two groups were similar, 2.21 vs 2.17(0-5yr vs 6-11yr. The median ABRs for spontaneous bleeds were 0.00 for both groups.
- Ancain (omfiloctocog alfa) / Sinocelltech
DESIGN OF A REAL-WORLD STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OMFILOCTOCOG ALFA IN PATIENTS RECEIVING PROPHYLACTIC TREATMENT FOR MODERATE OR SEVERE HEMOPHILIA A ([VIRTUAL]) - Feb 15, 2022 - Abstract #EAHAD2022EAHAD_398;
This real-world study will provide additional long-term effectiveness, safety and health economics data on prophylactic Omfiloctocog alfa in a large number of Chinese patients. These real-world date may be helpful in the goal of achieving universal access to prophylactic treatment in China.
- Ancain (omfiloctocog alfa) / Sinocelltech
DESIGN OF A REAL-WOLRD STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OMFILOCTOCOG ALFA IN PATIENTS RECEIVING PROPHYLACTIC TREATMENT FOR MODERATE OR SEVERE HEMOPHILIA A ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_235;
This real-world study will provide additional long-term effectiveness, safety and health economics data on prophylactic Omfiloctocog alfa in a large number of Chinese patients. These real-world date may be helpful in the goal of achieving universal access to prophylactic treatment in China.
- || omfiloctocog alfa (SCT800) / Sinocelltech
Clinical, PK/PD data, Journal: Pharmacokinetic, efficacy and safety evaluation of B-domain-deleted recombinant FVIII (SCT800) for prophylactic treatment in adolescent and adult patients with severe haemophilia A. (Pubmed Central) - Sep 26, 2021
These real-world date may be helpful in the goal of achieving universal access to prophylactic treatment in China. SCT800 has robust PK characteristics, and is safe and efficacious for the prophylaxis and treatment of bleeding episodes in previously treated adolescent and adult patients with severe haemophilia A.
- SCT800 / Sinocelltech
[VIRTUAL] A Multicenter Open-label Single Arm Trial to Evaluate Safety and Efficacy and Pharmacokinetics of Recombinant Human Coagulation Factor VIII (SCT800) in Previously Treated Patients with Severe Hemophilia A under Prophylaxis Therapy (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_1001;
P3
SCT800 has robust PK characteristics, and is safe and efficacious for the prophylaxis and treatment of bleeding episodes in previously treated adolescent and adult patients with severe haemophilia A. These results in adult Previous Treated Patients indicate that SCT800 is effective and safe for the prevention and treatment of bleeds in adults with severe hemophilia A.
- |||| Ancain (omfiloctocog alfa) / Sinocelltech
Enrollment open, Trial completion date, Trial primary completion date: Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients. (clinicaltrials.gov) - Apr 27, 2020
P4, N=240, Recruiting, Sponsor: Sinocelltech Ltd.
These results in adult Previous Treated Patients indicate that SCT800 is effective and safe for the prevention and treatment of bleeds in adults with severe hemophilia A. Not yet recruiting --> Recruiting | Trial completion date: Dec 2023 --> Apr 2025 | Trial primary completion date: Dec 2023 --> Apr 2025
- ||||| Ancain (omfiloctocog alfa) / Sinocelltech
Trial completion, Trial primary completion date: Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A (clinicaltrials.gov) - Feb 6, 2020
P3, N=73, Completed, Sponsor: Sinocelltech Ltd.
Not yet recruiting --> Recruiting | Trial completion date: Dec 2023 --> Apr 2025 | Trial primary completion date: Dec 2023 --> Apr 2025 Not yet recruiting --> Completed | Trial primary completion date: Aug 2019 --> Jan 2020
- ||||| Ancain (omfiloctocog alfa) / Sinocelltech
New P4 trial: Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients. (clinicaltrials.gov) - May 12, 2019
P4, N=240, Not yet recruiting, Sponsor: Sinocelltech Ltd.
- |||||||| Ancain (omfiloctocog alfa) / Sinocelltech
New P3 trial: Safety,Efficacy and Pharmacokinetics Evaluation of SCT800 in Previously Treated Paediatric Patients With Severe Haemophilia A. (clinicaltrials.gov) - May 12, 2019
P3, N=70, Not yet recruiting, Sponsor: Sinocelltech Ltd.
- |||||||| Ancain (omfiloctocog alfa) / Sinocelltech
New P3 trial: Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A (clinicaltrials.gov) - Jan 24, 2019
P3, N=68, Not yet recruiting, Sponsor: Sinocelltech Ltd.
- ||| Ancain (omfiloctocog alfa) / Sinocelltech
New P3 trial: Efficacy and Safety Study of SCT800 for On-demand Treatment With in Patients With Hemophilia A (clinicaltrials.gov) - Oct 3, 2016
P3, N=50, Not yet recruiting, Sponsor: Sinocelltech Ltd.
- | Ancain (omfiloctocog alfa) / Sinocelltech
New P1 trial: Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A (clinicaltrials.gov) - Sep 2, 2016
P1, N=16, Not yet recruiting, Sponsor: Sinocelltech Ltd.