NCT00623727 is a Phase 2 clinical trial of rFVIII-FS/pegylated liposomes (BAY79-4980) in Hemophilia A, sponsored by Bayer.

Who is sponsoring NCT00623727?

NCT00623727 is sponsored by Bayer.

What drugs are being tested in NCT00623727?

Interventions in NCT00623727: rFVIII-FS/pegylated liposomes (BAY79-4980), rFVIII-FS/WFI (BAY14-2222).

What condition does NCT00623727 study?

NCT00623727 studies Hemophilia A.

Is NCT00623727 still recruiting?

NCT00623727 is currently terminated. Last updated 8 July 2013.

Are results published for NCT00623727?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-07-08 · How we verify

NCT00623727

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

Randomized, Active-controlled, Double-blind, Parallel Design Study to Evaluate the Efficacy and Safety of a Once-a-week Prophylaxis Treatment With BAY79-4980 Compared to Three Times-per-week Prophylaxis With rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

Terminated Phase 2 Results posted Last updated 8 July 2013

What this trial tests

Phase 2 trial testing rFVIII-FS/pegylated liposomes (BAY79-4980) in Hemophilia A in 143 participants. Terminated before completion.

Timeline

1 June 2008

Primary endpoint
1 April 2010

1 October 2010

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	143
Start date	1 June 2008
Primary completion	1 April 2010
Estimated completion	1 October 2010
Sites	95 locations across United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia

Drugs / interventions tested

rFVIII-FS/pegylated liposomes (BAY79-4980) — full drug profile →
rFVIII-FS/WFI (BAY14-2222) — full drug profile →

Conditions studied

Hemophilia A — all drugs for Hemophilia A →

Sponsor

Bayer — full company profile →

Who can join

Adults 12 to 70, male only, with Hemophilia A. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants With Less Than 9 Total Bleeds Per Year
Time frame: up to one year
Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.

Sponsor's own description

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

New treatments in hemophilia: insights for the clinician.
Knobe K, Berntorp E. · · 2012 · cited 13× · PMID 23556123 · DOI 10.1177/2040620712440007

Verify or expand the search:

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 NCT00623727 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 8 July 2013

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/NCT00623727.

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