---
title: Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A
nct_id: NCT04845399
overall_status: COMPLETED
phase: PHASE3
sponsor: Zhengzhou Gensciences Inc
study_type: INTERVENTIONAL
primary_condition: Hemophilia A
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04845399.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04845399"
ct_last_update_post_date: 2023-08-29
last_seen_at: "2026-05-12T07:24:34.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A

**Official Title:** A Single-Arm, Multicenter, Open-label Phase III Expansion Trial Evaluating Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in Adolescent and Adult Patients With Hemophilia A

**NCT ID:** [NCT04845399](https://clinicaltrials.gov/study/NCT04845399)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 101
- **Lead Sponsor:** Zhengzhou Gensciences Inc
- **Collaborators:** Jiangsu Gensciences lnc.
- **Conditions:** Hemophilia A
- **Start Date:** 2021-04-16
- **Completion Date:** 2021-06-26
- **CT.gov Last Update:** 2023-08-29

## Brief Summary

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.

## Eligibility

- **Minimum age:** 12 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients Who have Completed trial of RH-107-001 (previously treated patients) Previously received Recombinant Human Coagulation Factor VIII-Fc prophylactic.
* The patient and/or guardian or his or her legal representative must be able to read, understand, and provide signed informed consent, And voluntarily signed the Informed Consent Form.
* The compliance of patients appeared quite well.
* Patient who is considered by the investigators suitable for ongoing to accept previously treated.

Exclusion Criteria:

* Subjects who have not completed trial of RH-107-001or who have completed the Phase III clinical trial but not willing to continue receiving treatment.
* Subjects who did not participate in the Phase III clinical trial of RH-107-001.
```

## Arms

- **Arm 1** (EXPERIMENTAL) — Participants will receive prophylaxis treatment with Recombinant Human Coagulation Factor VIII-Fc fusion for 6 months.

## Interventions

- **Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection** (DRUG) — 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.

## Primary Outcomes

- **Annualized Bleeding Rates (ABR).** _(time frame: For the duration of study participation, 6 months.)_ — 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.
- **Number of target joints.** _(time frame: For the duration of study participation, 6 months.)_ — 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.
- **Annualized Joint Bleeding Rate (AJBR)** _(time frame: For the duration of study participation, 6 months.)_ — 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).

## Secondary Outcomes

- **Total Dose Required for Resolution of a Bleeding Episode.** _(time frame: For the duration of study participation, 6 months.)_
- **Number of injections required to resolve a bleeding episode.** _(time frame: For the duration of study participation, 6 months.)_
- **Quality of life assessment.** _(time frame: For the duration of study participation, 6 months.)_
- **Score of bleeding symptoms and Vital signs.** _(time frame: For the duration of study participation, 6 months.)_
- **Number of participants with inhibitor development** _(time frame: For the duration of study participation, 6 months.)_
- **Number of Participants With Incidence of Antibody Formation to CHINESE HAMSTER OVARY (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.** _(time frame: For the duration of study participation, 6 months.)_

## Locations (16)

- Anhui Provincial Hospital, Hefei, Anhui, China
- Capital Medical University affiliated Beijing Children's Hospital, Beijing, Beijing Municipality, China
- Chongqing Three Gorges Central Hospital, Chongqing, Chongqing Municipality, China
- The First Hospital of Lanzhou University, Lanzhou, Gansu, China
- The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangzhou, China
- Nanfang Hospital of Southern Medical University, Guangzhou, Guangzhou, China
- The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
- Henan provincial People's Hospital, Zhengzhou, He'nan, China
- Henan Cancer Hospital, Zhengzhou, He'nan, China
- Xiangya Hospital of Central South University, Changsha, Hunan, China
- The Affiliated Hospital of Xuzhou Medical College, Xuzhou, Jiangsu, China
- Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China
- Jinan central hospital, Ji'nan, Shandong, China
- The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
- The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
- Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College., Tianjin, Tianjin Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.anhui provincial hospital|hefei|anhui|china` — added _(2026-05-12)_
- `locations.capital medical university affiliated beijing children's hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.chongqing three gorges central hospital|chongqing|chongqing municipality|china` — added _(2026-05-12)_
- `locations.the first hospital of lanzhou university|lanzhou|gansu|china` — added _(2026-05-12)_
- `locations.the second affiliated hospital of guangzhou medical university|guangzhou|guangzhou|china` — added _(2026-05-12)_
- `locations.nanfang hospital of southern medical university|guangzhou|guangzhou|china` — added _(2026-05-12)_
- `locations.the affiliated hospital of guizhou medical university|guiyang|guizhou|china` — added _(2026-05-12)_
- `locations.henan provincial people's hospital|zhengzhou|he'nan|china` — added _(2026-05-12)_
- `locations.henan cancer hospital|zhengzhou|he'nan|china` — added _(2026-05-12)_
- `locations.xiangya hospital of central south university|changsha|hunan|china` — added _(2026-05-12)_
- `locations.the affiliated hospital of xuzhou medical college|xuzhou|jiangsu|china` — added _(2026-05-12)_
- `locations.jiangxi provincial people's hospital|nanchang|jiangxi|china` — added _(2026-05-12)_
- `locations.jinan central hospital|ji'nan|shandong|china` — added _(2026-05-12)_
- `locations.the affiliated hospital of qingdao university|qingdao|shandong|china` — added _(2026-05-12)_
- `locations.the second hospital of shanxi medical university|taiyuan|shanxi|china` — added _(2026-05-12)_
- `locations.institute of hematology & blood diseases hospital chinese academy of medical sciences & peking union medical college.|tianjin|tianjin municipality|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04845399*  
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