Who is sponsoring NCT01561417?

NCT01561417 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT01561417?

Interventions in NCT01561417: activated recombinant human factor VII, activated recombinant human factor VII.

What condition does NCT01561417 study?

NCT01561417 studies Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Healthy.

Is NCT01561417 still recruiting?

NCT01561417 is currently completed. Last updated 18 January 2017.

Last reviewed 2017-01-18 · How we verify

NCT01561417

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

A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)

Completed Phase 1 Last updated 18 January 2017

What this trial tests

Phase 1 trial testing activated recombinant human factor VII in Acquired Bleeding Disorder in 28 participants. Completed in 1 September 2006.

Timeline

1 April 2006

Primary endpoint
1 September 2006

1 September 2006

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	28
Start date	1 April 2006
Primary completion	1 September 2006
Estimated completion	1 September 2006
Sites	1 location across France

Drugs / interventions tested

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

Conditions studied

Acquired Bleeding Disorder — all drugs for Acquired Bleeding Disorder →
Acquired Haemophilia — all drugs for Acquired Haemophilia →
Congenital Bleeding Disorder — all drugs for Congenital Bleeding Disorder →
Congenital FVII Deficiency — all drugs for Congenital FVII Deficiency →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 45, male only, with Acquired Bleeding Disorder or Acquired Haemophilia. 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.

Area under the plasma concentration versus time curve for FVIIa clot activity

Sponsor's own description

This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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 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 NCT01561417 (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 Novo Nordisk A/S
Last refreshed: 18 January 2017

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/NCT01561417.

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