NCT05395858 (REAL) is a clinical trial of No intervention in Hemophilia A, sponsored by Bayer.

Who is sponsoring NCT05395858?

NCT05395858 is sponsored by Bayer.

What drugs are being tested in NCT05395858?

Interventions in NCT05395858: No intervention.

What condition does NCT05395858 study?

NCT05395858 studies Hemophilia A.

Is NCT05395858 still recruiting?

NCT05395858 is currently terminated. Last updated 28 November 2023.

Last reviewed 2023-11-28 · How we verify

NCT05395858: REAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Learn More About Treatment With Damoctocog Alfa Pegol, How it is Used in Every Day Practice ("Real-World"), and How Satisfied People Who Receive Damoctocog Alfa Pegol Are in United States (US) Hemophilia Treatment Centers

Terminated Last updated 28 November 2023

What this trial tests

trial testing No intervention in Hemophilia A in 14 participants. Terminated before completion.

Timeline

17 January 2023

Primary endpoint
6 November 2023

6 November 2023

Quick facts

Lead sponsor	Bayer
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	14
Start date	17 January 2023
Primary completion	6 November 2023
Estimated completion	6 November 2023
Sites	3 locations across United States

Drugs / interventions tested

No intervention

Conditions studied

Hemophilia A — all drugs for Hemophilia A →

Sponsor

Bayer — full company profile →

Who can join

12 and older, any sex, with Hemophilia A. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

People with hemophilia A do not have enough of a protein found naturally in the blood called "clotting factor 8", also known as FVIII. This protein helps the blood to clump together to prevent and stop bleeding. People with lower levels of FVIII or FVIII that does not work properly may bleed for a long time from minor wounds, bleed into their joints, or have internal bleeding. The study treatment, Jivi (also called damoctocog alfa pegol), is already available as a treatment for people aged 12 years and older with hemophilia A, to help prevent bleeding, also known as "prophylactic" treatment. It works by replacing the missing FVIII, or the FVIII that does not work properly. It can also be used to stop bleeding that has already occurred and prior to surgery to prevent bleeding. The main goal of this study is to learn how damoctocog alfa pegol is used in the "real world" as a treatment in the United States (US) and how well it works and what other treatments patients use while receiving damoctocog alfa pegol treatment. It will also determine how satisfied people are with the treatment. There will be no required visits with a study doctor in this study. The study will include about 20 male or female patients in the US aged 12 years and over who have hemophilia A. All the patients in this study will have switched from their previous FVIII replacement treatment to damoctocog alfa pegol. While the patients are receiving damoctocog alfa pegol, they will complete a survey to say how they feel about the treatment. Their doctors will also record information about their treatment with damoctocog alfa pegol and how well it is working. This study will collect information from the patients' medical records and surveys. They will use this information to find out more about treatment with damoctocog alfa pegol under "real world" conditions. They will look at: * how often the patients receive damoctocog alfa pegol and how much they use * what other treatments the patients received before receiving damoctocog alfa pegol, how they used it and how much they used * how well damoctocog alfa pegol works at preventing bleeding, and how it compares to previous products used.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other recruiting trials for Hemophilia A

Currently open trials in the same condition.

NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT07416604 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A · Phase 3 · recruiting
NCT07523399 — Joint Health, Balance and Quality of Life in Adults With Hemophilia A · recruiting
NCT06833983 — To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A · Phase 3 · recruiting
NCT06579144 — Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A · Phase 1 · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05395858 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 28 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05395858.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing