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Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation

NCT ID: NCT01562158

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2003-10-31

Brief Summary

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This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.

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Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers

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Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors +1 more
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Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

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Detailed Description

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Conditions

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Acquired Bleeding Disorder Bleeding During/Following Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

standard therapy

Intervention Type PROCEDURE

Standard treatment of bleeding

placebo

Intervention Type DRUG

Placebo

Low dose

Group Type EXPERIMENTAL

standard therapy

Intervention Type PROCEDURE

Standard treatment of bleeding

activated recombinant human factor VII

Intervention Type DRUG

Two days repeated treatment regimen - low dose administered i.v. (into the vein)

Medium dose

Group Type EXPERIMENTAL

standard therapy

Intervention Type PROCEDURE

Standard treatment of bleeding

activated recombinant human factor VII

Intervention Type DRUG

Two days repeated treatment regimen - medium dose administered i.v. (into the vein)

High dose

Group Type EXPERIMENTAL

standard therapy

Intervention Type PROCEDURE

Standard treatment of bleeding

activated recombinant human factor VII

Intervention Type DRUG

Two days repeated treatment regimen - high dose administered i.v. (into the vein)

Interventions

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standard therapy

Standard treatment of bleeding

Intervention Type PROCEDURE

activated recombinant human factor VII

Two days repeated treatment regimen - low dose administered i.v. (into the vein)

Intervention Type DRUG

activated recombinant human factor VII

Two days repeated treatment regimen - medium dose administered i.v. (into the vein)

Intervention Type DRUG

activated recombinant human factor VII

Two days repeated treatment regimen - high dose administered i.v. (into the vein)

Intervention Type DRUG

placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have undergone allogeneic or autologous stem cell transplantation

Exclusion Criteria

* Known or suspected allergy to trial product
* Participation in other trials with unapproved drugs or trials with equal or similar objective
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Chapel Hill, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Herston, , Australia

Site Status

Novo Nordisk Investigational Site

Parkville, , Australia

Site Status

Novo Nordisk Investigational Site

Westmead, , Australia

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Copenhagen, , Denmark

Site Status

Novo Nordisk Investigational Site

Helsinki, , Finland

Site Status

Novo Nordisk Investigational Site

Besançon, , France

Site Status

Novo Nordisk Investigational Site

Lille, , France

Site Status

Novo Nordisk Investigational Site

Tours, , France

Site Status

Novo Nordisk Investigational Site

Cologne, , Germany

Site Status

Novo Nordisk Investigational Site

Dresden, , Germany

Site Status

Novo Nordisk Investigational Site

Hamburg, , Germany

Site Status

Novo Nordisk Investigational Site

Hanover, , Germany

Site Status

Novo Nordisk Investigational Site

Idar-Oberstein, , Germany

Site Status

Novo Nordisk Investigational Site

München, , Germany

Site Status

Novo Nordisk Investigational Site

Regensburg, , Germany

Site Status

Novo Nordisk Investigational Site

Tübingen, , Germany

Site Status

Novo Nordisk Investigational Site

Wiesbaden, , Germany

Site Status

Novo Nordisk Investigational Site

Haifa, , Israel

Site Status

Novo Nordisk Investigational Site

Jerusalem, , Israel

Site Status

Novo Nordisk Investigational Site

Florence, , Italy

Site Status

Novo Nordisk Investigational Site

Genova, , Italy

Site Status

Novo Nordisk Investigational Site

Pesaro, , Italy

Site Status

Novo Nordisk Investigational Site

Rome, , Italy

Site Status

Novo Nordisk Investigational Site

Udine, , Italy

Site Status

Novo Nordisk Investigational Site

Gdansk, , Poland

Site Status

Novo Nordisk Investigational Site

Katowice, , Poland

Site Status

Novo Nordisk Investigational Site

Poznan, , Poland

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Wroclaw, , Poland

Site Status

Novo Nordisk Investigational Site

Wroclaw, , Poland

Site Status

Novo Nordisk Investigational Site

Singapore, , Singapore

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Santander, , Spain

Site Status

Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Novo Nordisk Investigational Site

Gothenburg, , Sweden

Site Status

Novo Nordisk Investigational Site

Stockholm, , Sweden

Site Status

Novo Nordisk Investigational Site

Uppsala, , Sweden

Site Status

Novo Nordisk Investigational Site

Basel, , Switzerland

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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United States Australia Austria Denmark Finland France Germany Israel Italy Poland Singapore Spain Sweden Switzerland Thailand United Kingdom

References

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Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B; F7BMT-1360 Trial Investigators. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005 Sep;3(9):1935-44. doi: 10.1111/j.1538-7836.2005.01523.x.

Reference Type RESULT
PMID: 16102099 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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F7BMT-1360

Identifier Type: -

Identifier Source: org_study_id

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