Who is sponsoring NCT01561391?

NCT01561391 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT01561391?

Interventions in NCT01561391: activated recombinant human factor VII, activated recombinant human factor VII, factor IX, factor VIII.

What condition does NCT01561391 study?

NCT01561391 studies Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors.

Is NCT01561391 still recruiting?

NCT01561391 is currently completed. Last updated 27 December 2023.

Last reviewed 2023-12-27 · How we verify

NCT01561391

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

An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery

Completed Phase 4 Last updated 27 December 2023

What this trial tests

Phase 4 trial testing activated recombinant human factor VII in Congenital Bleeding Disorder in 36 participants. Completed in 1 May 2004.

Timeline

1 April 1998

Primary endpoint
1 May 2004

1 May 2004

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 April 1998
Primary completion	1 May 2004
Estimated completion	1 May 2004
Sites	14 locations across United States

Drugs / interventions tested

activated recombinant human factor VII — full drug profile →
activated recombinant human factor VII — full drug profile →
factor IX — full drug profile →
factor VIII — full drug profile →

Conditions studied

Congenital Bleeding Disorder — all drugs for Congenital Bleeding Disorder →
Haemophilia A With Inhibitors — all drugs for Haemophilia A With Inhibitors →
Haemophilia B With Inhibitors — all drugs for Haemophilia B With Inhibitors →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

5 and older, any sex, with Congenital Bleeding Disorder or Haemophilia A With Inhibitors. 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.

Presence and maintenance of haemostasis
Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII

Sponsor's own description

This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.

Publications & conference data

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

Recombinant factor VIIa concentrate versus plasma-derived concentrates for treating acute bleeding episodes in people with haemophilia and inhibitors.
Matino D, Makris M, Dwan K, D'Amico R, et al · · 2015 · cited 5× · PMID 26677005 · DOI 10.1002/14651858.cd004449.pub4

Verify or expand the search:

Other trials of activated recombinant human factor VII

Trials testing the same drug.

NCT00124293 — Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumati · completed
NCT01564563 — Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoiet · Phase 2 · terminated

Other recruiting trials for Congenital Bleeding Disorder

Currently open trials in the same condition.

NCT06574984 — Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · 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 NCT01561391 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Novo Nordisk A/S
Last refreshed: 27 December 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/NCT01561391.

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