2-cohort Study of Adult Patients With Severe Hemophilia A in Greece

NCT02319070 | Completed

• 2 other identifiers: 17493KG1411GR
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single center, observational, 2-cohort study of adult patients with severe Hemophilia A. There is no randomization procedure and all patients will be treated as per usual clinical practice. Patients will be followed up for 18 months after enrolment.

Conditions

Hemophilia A

Keywords

Cost; Clinical Outcomes; Quality of Life; On Demand Treatment; Secondary Prophylaxis

Outcome Measures

Primary Outcomes (2)

• Annual direct medical cost of specialized hemophilia centre for patients with the on-demand strategy

  At 18 months

• Annual direct medical cost of specialized hemophilia centre for patients with secondary prophylaxis

  At 18 months

Secondary Outcomes (9)

• Mean cost per joint bleed episodes for overall patients

  At 18 months

• Mean cost per joint bleed episodes by cohort for patients

  At 18 months

• Number of joint bleed episodes for overall patients

  At 18 months

• Number of joint bleed episodes by cohort for patients.

  At 18 months

• Severity of joint bleed episodes for overall patients.

  At 18 months

Study Arms (2)

Cohort 1

Adult patients with severe Hemophilia A.(25 patients on Secondary Prophylaxis treatment)

Other: Survey

Cohort 2

Adult patients with severe Hemophilia A.(50 patients on On Demand treatment)

Other: Survey

Interventions

Survey OTHER

Recombinant antihemophilic factor VIII (FVIII) on Secondary Prophylaxis treatment scheduled according to daily routine

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This will be a single center prospective two-cohort observational study conducted in a hospital setting.Patients will be enrolled from the biggest specialty management center in Greece

You may qualify if:

• Patients diagnosed with severe Hemophilia A.
• Age ≥18 years old
• Patients able to read and write
• Patients receiving Factor VIII substitute therapy, either on-demand or as secondary prophylaxis.
• Patients under the same therapeutic strategy (On Demand or Secondary Prophylaxis) for at least 6 months prior to enrolment.

You may not qualify if:

• Patients that have developed inhibitors against factor VIII.
• Patients participating in an investigational program with interventions outside of routine clinical practice.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Greece

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 18, 2014
• Study Start: January 13, 2015
• Primary Completion: May 28, 2017
• Study Completion: February 28, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

GR (1)