NCT02554526

Brief Summary

Using whole blood samples and plasma samples obtained from some hemophilia A patients with inhibitors, the investigators will perform the coagulation assessment in the co-presence of aPCC and factor VIII by comprehensive coagulation assays and flow chamber analysis under blood flow conditions.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

1.5 years

First QC Date

September 15, 2015

Last Update Submit

September 17, 2015

Conditions

Hemophilia A With Inhibitor

Keywords

hemophilia Ainhibitorbypassing therapyfactor VIII

Outcome Measures

Primary Outcomes (2)

  • Evaluation of coagulation effects using patients' plasmas by FXa/thrombin/plasmin generation tests and clot waveform analysis

    up to 10 months

  • Evaluation of coagulation effects using patients' whole bloods by ROTEM and T-TAS

    up to 15 months

Study Arms (1)

Combination therapy

Effects of aPCC reaction in the presence of FVIII

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We guess that there are approximately 200-300 hemophilia A patients with inhibitors in our country. We have approximately 20 out-patients in our hospital. Based on this information, we set up the patients subjects (n=10).

You may qualify if:

  • Patients with hemophilia A with inhibitors (Inhibitor titer; \>0.5 Bethesda U/ml)
  • Patients with agreement consents with the patients signatures

You may not qualify if:

  • Patients that do not fill the conditions described above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics

Kashihara, Nara, 634-8522, Japan

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

  • Midori Shima, MD, PhD

    Nara Medical University

    STUDY DIRECTOR

Central Study Contacts

Keiji Nogami, MD, PhD

CONTACT

+81-744-29-8881roc-noga@naramed-u.ac.jp

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 18, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

JP(1)