Efficacy and Safety Study of SCT800 for On-demand Treatment With in Patients With Hemophilia A

NCT02921945 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-10-03

No results posted yet for this study

Summary

In this trial safety and efficacy of SCT800 (B-domain deleted recombinant factor VIII) is being evaluated in 50 subjects, 12 to 65 years of age, with moderate to severe Hemophilia A. These subjects will receive open label treatment with SCT800 for approximately 6 months for on-demand treatment.

Conditions

Interventions

BIOLOGICAL

SCT800

recombinant human coagulation factor VIII

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Principal Investigators

  • Xielan Zhao, PhD · Xiangya Hospital of Centre-South University, Changsha, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-12-31
Completion
2018-06-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02921945 on ClinicalTrials.gov