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NCT01564563
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
Phase 2 trial testing standard therapy in Acquired Bleeding Disorder in 11 participants. Terminated before completion.
27 October 2003
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 28 June 2002 |
| Primary completion | 27 October 2003 |
| Estimated completion | 27 October 2003 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- standard therapy — full drug profile →
- placebo
- 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 →
- Bleeding During/Following Surgery — all drugs for Bleeding During/Following Surgery →
Sponsor
Novo Nordisk A/S — full company profile →
Who can join
12 and older, any sex, with Acquired Bleeding Disorder or Bleeding During/Following Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem cell transplantation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01564563
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01564563 (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: 27 February 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/NCT01564563.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing