NCT02284789

Brief Summary

To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a population of adults with moderate to severe hemophilia A treated with coagulation factor VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

November 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

November 4, 2014

Last Update Submit

December 2, 2015

Conditions

Hemophilia A

Keywords

Hemophilia

Outcome Measures

Primary Outcomes (1)

  • Colorado Adult Joint Assessment Score (CAJAS)

    Up to 25 days

Study Arms (1)

CAJAS evaluation

OTHER
Other: Colorado Adult Joint Assessment Evaluation

Interventions

Colorado Adult Joint Assessment EvaluationOTHER

Physical evaluation of 6 joints, ankles, knees and elbows

CAJAS evaluation

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male, 18 to 50 years of age
  • Diagnosis of moderate to severe hemophilia A (documented \<1-2% Factor VIII Concentration \[FVIII:C\])
  • Willing to maintain current FVIII treatment regimen, whether prophylactic or on-demand, for the duration of the study

You may not qualify if:

  • Routine need for wheelchair or routine need for two canes or crutches
  • Diagnosis of another bleeding disorder such as von Willebrand Disease
  • Known event that would interfere with the scheduled CAJAS evaluations (e.g., elective joint surgery, vacation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Indianapolis, Indiana, 46260, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

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

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 6, 2014

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(4)