Hemophilia ANCT02971930

Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

An observational study of Hemophilia A, run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is to generate qualitative data to evaluate the impact of frequency of FVIII infusions on patients' satisfaction with treatment and their quality of life. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hemophilia A
What is being tested?: BAY94-9027
Type of treatment: Injection or infusion
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 20 Jun 2017to 15 Dec 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population consists of patients aged 18+ years who are participating in the BAY94-9027 extension studies or who are within 3 months of exiting the study.

Who may be able to join

Patient is enrolled in the BAY94-9027 extension studies or is within 3 months of having completed participation in the BAY94-9027 extension studies;
Patient allocated to Arm 2, Arm 3 or Arm 4 of BAY94-9027 extension studies.
Arm 2 Prophylaxis treatment of BAY94-9027; 2 infusions per week during the extension study
Arm 3 Prophylaxis treatment of BAY94-9027; infusion every 5 days during the extension study
Arm 4 Prophylaxis treatment of BAY94-9027; every 7 days during the extension study
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
Patient must be willing and able to participate in a telephone interview lasting up to 30 minutes;
Patient must have sufficient cognitive and linguistic capacities to allow them to actively participate in an interview lasting 30 minutes.

Who cannot join

Patient is part of Arm 1: On-demand treatment of BAY94-9027 at individual dose and number of infusions based upon location and severity of bleeds;
Patient is unlikely to comply with the study protocol (e.g. uncooperative attitude) or unlikely to complete the study for any reason in the opinion of the recruiter;
Patient has great difficulty hearing or reading;
Patient has any significant comorbid condition (including uncontrolled psychiatric conditions) that might limit or interfere with their ability to talk about their Hemophilia A and participate in the study;
Patient has severe neurological or cognitive deficits that might affect their ability to participate in an interview.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland
Cleveland, Ohio, 110605

Other trials in United States

About this study

This study is to generate qualitative data to evaluate the impact of frequency of FVIII infusions on patients' satisfaction with treatment and their quality of life.

Conditions: Hemophilia A
Being tested: BAY94-9027
Medical subject headings: Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAY94-9027Biological
Intravenous infusion of BAY94-9027

Study groups in NCT02971930
Study group	Role	What they receive
Prophylaxis treatment of BAY94-9027_1		2 infusions per week during the extension study Receives: Biological: BAY94-9027
Prophylaxis treatment of BAY94-9027_2		infusion every 5 days during the extension study Receives: Biological: BAY94-9027
Prophylaxis treatment of BAY94-9027_3		every 7 days during the extension study Receives: Biological: BAY94-9027

What is being measured

The primary outcome is the main question the study is designed to answer.

Qualitative interviews (with patients) to determine patients' satisfaction
To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences satisfaction
Measured: up to 4 months
Qualitative interviews (with patients) to determine patients' quality of life
To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences quality of life;
Measured: up to 4 months
Qualitative interviews (with treating physicians) to determine patients' satisfaction
To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' satisfaction
Measured: up to 4 months
Qualitative interviews (with treating physicians) to determine patients' quality of life
To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' quality of life;
Measured: up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201715 Dec 2017

First posted23 Nov 2016 (estimated)
Study start20 Jun 2017
Primary completion26 Nov 2017
Study completion15 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hemophilia AStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02971930
Sponsor's protocol ID: 19144
Status last verified: Jan 2018
First submitted: 27 Oct 2016
Last updated: 1 Feb 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

All Hemophilia A trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A
ClinicalTrials.gov ID: NCT02971930
Acronym / sponsor ID: 19144
Conditions: Hemophilia A
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 20 Jun 2017 (actual)
Primary completion: 26 Nov 2017 (actual)
Study completion: 15 Dec 2017 (actual)
First posted: 23 Nov 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is to generate qualitative data to evaluate the impact of frequency of FVIII infusions on patients' satisfaction with treatment and their quality of life.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Prophylaxis treatment of BAY94-9027_1	–	Biological: BAY94-90272 infusions per week during the extension study
Prophylaxis treatment of BAY94-9027_2	–	Biological: BAY94-9027infusion every 5 days during the extension study
Prophylaxis treatment of BAY94-9027_3	–	Biological: BAY94-9027every 7 days during the extension study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population consists of patients aged 18+ years who are participating in the BAY94-9027 extension studies or who are within 3 months of exiting the study.

Key inclusion criteria (8 listed)

Patient is enrolled in the BAY94-9027 extension studies or is within 3 months of having completed participation in the BAY94-9027 extension studies;
Patient allocated to Arm 2, Arm 3 or Arm 4 of BAY94-9027 extension studies.
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
Patient must be willing and able to participate in a telephone interview lasting up to 30 minutes;
Patient must have sufficient cognitive and linguistic capacities to allow them to actively participate in an interview lasting 30 minutes.

Key exclusion criteria (5 listed)

Patient is part of Arm 1: On-demand treatment of BAY94-9027 at individual dose and number of infusions based upon location and severity of bleeds;
Patient is unlikely to comply with the study protocol (e.g. uncooperative attitude) or unlikely to complete the study for any reason in the opinion of the recruiter;
Patient has great difficulty hearing or reading;
Patient has any significant comorbid condition (including uncontrolled psychiatric conditions) that might limit or interfere with their ability to talk about their Hemophilia A and participate in the study;
Patient has severe neurological or cognitive deficits that might affect their ability to participate in an interview.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BAY94-9027Intravenous infusion of BAY94-9027	Biological	Prophylaxis treatment of BAY94-9027_1, Prophylaxis treatment of BAY94-9027_2, Prophylaxis treatment of BAY94-9027_3

Primary outcome

Qualitative interviews (with patients) to determine patients' satisfaction
Time frame: up to 4 months
To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences satisfaction
Qualitative interviews (with patients) to determine patients' quality of life
Time frame: up to 4 months
To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences quality of life;
Qualitative interviews (with treating physicians) to determine patients' satisfaction
Time frame: up to 4 months
To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' satisfaction
Qualitative interviews (with treating physicians) to determine patients' quality of life
Time frame: up to 4 months
To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' quality of life;

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.

Related trials for Hemophilia A

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hemophilia A, run by Bayer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative interviews (with patients) to determine patients' satisfaction (time frame: up to 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02971930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.