Trials Sponsors Conditions Drugs Pricing

Conditions

Congenital Hemophilia A

Outcome Measures

Primary Outcomes (8)

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.

Secondary Outcomes (20)

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
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

Study Arms (1)

rVIII-SingleChain

EXPERIMENTAL

Participants will receive rVIII-SingleChain as an intravenous (IV) infusion for a minimum of 50 exposure days (EDs).

Biological: Recombinant single-chain factor VIII (rVIII-SingleChain)

Interventions

Recombinant single-chain factor VIII (rVIII-SingleChain)Biological

Lyophilized powder for solution for intravenous injection

Also known as: CSL627

rVIII-SingleChain

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age0 Days - 65 Years

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Male Chinese participants \<= 65 years of age.
Participants with severe hemophilia A (FVIII activity \< 1%).

Sponsors & Collaborators

CSL Behring
Industrylead

Study Sites (20)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Beijing Children's Hospital

Beijing, Beijing Municipality, 100045, China

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 515399, China

Liuzhou People's Hospital

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Study Director
CSL Behring
STUDY DIRECTOR

Enrollment

62 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

January 9, 2025

Actual (reported)

Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (20)

Study Arms (1)

rVIII-SingleChain

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (20)

Study Arms (1)

rVIII-SingleChain

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations