Trial · NCT05265286
A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
NCT05265286, Phase 2, Completed, Hangzhou Gensciences Biopharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection. Trials, record NCT05265286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05265286
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
- NCT number
- NCT05265286
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
- Conditions
- Severe Hemophilia A
- Interventions
- FRSW117
- First posted
- 2022-03-03
- Last updated
- 2023-05-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum measured concentration of FVIII:C (Cmax) | Pre-dose and post dose up to 10 days | Measured by One-Stage Clotting Assay |
| Primary | Time required for the concentration of the drug to reach half of its original value (T1/2) | Pre-dose and post dose up to 10 days | Measured by One-Stage Clotting Assay |
| Primary | Area Under the Curve to Infinity (AUC) | Pre-dose and post dose up to 10 days | Measured by One-Stage Clotting Assay |
| Primary | The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time (CL) | Pre-dose and post dose up to 10 days | Measured by One-Stage Clotting Assay |
| Primary | Evaluation of the level of anti-PEG-rFⅧFc antibody production in participants | Pre-dose and post dose up to 36 days | |
| Primary | Evaluation of the level of anti-PEG antibody production in participants | Pre-dose and post dose up to 36 days | |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE V5.0 | Pre-dose and post dose up to 36 days | Adverse events related to PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0. |
| Secondary | Development of Inhibitor | Pre-dose and post dose up to 36 days | Measured by the Nijmegen-Modified Bethesda Assay |
| Secondary | score of bleeding symptoms and Vital signs | Pre-dose and post dose up to 36 days | Response to treatment with PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for bleeding episodes, using the 4-point bleeding response scale |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05265286
GET https://conductscience.org/api/trials/v1/NCT05265286/registered