Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia

Completed

• Conditions: Haemophilia B With Inhibitors; Haemophilia A With Inhibitors; Haemophilia B; Congenital Bleeding Disorder; Haemophilia A
• Interventions: Other: No treatment given

• Registration Number: NCT01988532
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in the United States of America (USA). The aim of the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors with joint bleeding.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 381

Inclusion Criteria

• Adult males able to provide consent and complete a survey in English
• Congenital hemophilia A or B with or without inhibitors with any history of joint bleeding or joint pain
• Presentation at the treatment center for a comprehensive annual visit where joint range of motion will be obtained
• Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)

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Exclusion Criteria

• Previous participation in this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult PWH	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Prevalence of acute (bleed-related) pain (percentage)	At the first visit (only one study visit)
Prevalence of chronic (arthritic) pain (percentage)	At the first visit (only one study visit)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Plainsboro, New Jersey, United States