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Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A

NCT02888223 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-09-02

No results posted yet for this study

Summary

Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).

Conditions

Interventions

BIOLOGICAL

SCT800

BIOLOGICAL

Xyntha

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-02-28
Completion
2017-07-31

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT02888223 on ClinicalTrials.gov