NCT02921945

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

September 28, 2016

Last Update Submit

September 29, 2016

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (1)

  • Incremental Recovery (K-value)

    One-stage aPTT Assay

    1hour after the end of the infusion

Secondary Outcomes (5)

  • Haemostatic effect of SCT800 evaluated according to a predefined four grade scale: excellent, good, moderate, or no response

    Up to 6 months

  • The incidence rate of FVIII inhibitors (≥0.6 BU)

    Up to 6 months

  • The number of infusions of SCT800 required per bleeding episode

    Up to 6 months

  • Actual consumption of SCT800 (IU/Kg/bleed)

    Up to 6 months

  • AEs related to SCT800 during the clinical study

    Up to 6 months

Study Arms (1)

SCT800

EXPERIMENTAL
Biological: SCT800

Interventions

SCT800BIOLOGICAL

recombinant human coagulation factor VIII

SCT800

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years old;
  • The activity of the coagulation factor VIII (FVIII:C) ≤5%, and was previously treated with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
  • Bleeding state need to be treated with FVIII;
  • Negative assays for FVIII inhibitors (\<0.6 BU/mL);
  • The platelet count is normal；
  • Normal prothrombin time or INR ≤1.5；
  • Given informed consent

You may not qualify if:

  • Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
  • Family history or history of FVIII inhibitors (≥0.6 Bethesda Units \[BU\] mL-1);
  • Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days prior to study entry (including rFVIII, plasma-derived factor VIII \[pdFVIII\], cryoprecipitate and whole blood);
  • Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
  • HIV seropositive;
  • Abnormal hemostasis from causes other than hemophilia A；
  • Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level);
  • Patients who received any anticoagulant or antiplatelet therapy within one week (including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials;
  • Alcoholism, drug abuse, mental disorders and mental retardation;
  • Elective surgery planned during the process of study;
  • Patients who previously participated in the other clinical trials prior to study entry;
  • The patient or parent/legal guardian is unable or unwilling to sign an informed consent form or to comply with the requirements of clinical protocol;
  • Other conditions confirmed by the researchers, resulting in that patients are unable to benefit from clinical observation;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Centre-South University

Changsha, Hunan, 410008, China

Location

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

  • Xielan Zhao, PhD

    Xiangya Hospital of Centre-South University, Changsha, China

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 3, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

October 3, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)