A Phase 3 interventional study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Hemophilia A, sponsored by Zhengzhou Gensciences Inc. Completed at 16 sites in China. Open to male participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Zhengzhou Gensciences Inc · Phase 3, Interventional, and Treatment
The primary objectives of the study are to further evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in adolescent and adult patients with hemophilia A.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 101 is above the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Zhengzhou Gensciences Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive prophylaxis treatment with Recombinant Human Coagulation Factor VIII-Fc fusion for 6 months.
Drug: Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Participants received prophylaxis treatment at 50 IU/ kg every three days.30-50 IU/kg is recommended to administration while bleeding occurs during the experiment.
Annualized Bleeding Rates (ABR).
Annualized bleeding rate = (number of bleeding episodes during the efficacy, period/total number of days during the efficacy period)\*365.25. The efficacy period begins with the first prophylactic dose of FRSW107 and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.
Time frame: For the duration of study participation, 6 months.
Number of target joints.
Describe the number and percentage of cases with target joints ≥1 and their 95% confidence intervals before and after drug administration, and compare the change in the number of target joints from baseline after treatment.
Time frame: For the duration of study participation, 6 months.
Annualized Joint Bleeding Rate (AJBR)
Annualized joint bleeding rate(AJBR)can be calculated using the following formula: Number of joint bleeding episodesevents during efficacy evaluation period/(number of days in treatment period/365.25).
Time frame: For the duration of study participation, 6 months.
Total Dose Required for Resolution of a Bleeding Episode.
The total dose required to resolve a bleeding episode per participant, based on the efficacy period. The efficacy period begins with the first dose and ends with the last dose (for a bleed). For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleed is averaged across all bleeding episodes per participant.
Time frame: For the duration of study participation, 6 months.
Number of injections required to resolve a bleeding episode.
The number of injections required to resolve a bleeding episode per participant, based on the efficacy period. The efficacy period begins with the first dose and ends with the last dose (for a bleed). All injections given from the initial sign of a bleed, until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. For 'Per participant' values, the number of injections required to resolve each bleed is averaged across all bleeding episodes per participant.
Time frame: For the duration of study participation, 6 months.
Quality of life assessment.
Quality of life assessment by Haemophilia Joint Health Score(HJHS 2.1).
Time frame: For the duration of study participation, 6 months.
Score of bleeding symptoms and Vital signs.
Response to treatment with rFVIIIFc for bleeding episodes, using the 4-point bleeding response scale.
Time frame: For the duration of study participation, 6 months.
Number of participants with inhibitor development
Number of participants who developed a positive FVIII inhibitor level (≥0.6 Bethesda unit \[BU\]) during the study was summarized and classified as participants developing low titer inhibitor (i.e. ≤ 5.0 BU) and participants developing high titer inhibitor (i.e. \> 5.0 BU).
Time frame: For the duration of study participation, 6 months.
Number of Participants With Incidence of Antibody Formation to CHINESE HAMSTER OVARY (CHO).
A test to analyze the formation of antibodies to CHO.
Time frame: For the duration of study participation, 6 months.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events. (SAEs) as a Measure of Safety and Tolerability.
An AE is any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition.
Time frame: For the duration of study participation, 6 months.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhengzhou Gensciences Inc