Efficacy and Safety of Activated Recombinant Human Factor... | NCT01564563

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

NCT01564563

Sponsor

Novo Nordisk A/S

Status

Terminated

Last Update Posted

Feb 27, 2017Actual

Enrollment

11Actual

Phase

Phase 2

Conditions

Acquired Bleeding Disorder
Bleeding During/Following Surgery

Interventions

standard therapy
placebo
activated recombinant human factor VII
activated recombinant human factor VII

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Trial enrollment was prematurely terminated due to excessively slow patient recruitment

Expanded Access Info

Start Date

Jun 28, 2002Actual

Primary Completion Date

Oct 27, 2003Actual

Completion Date

Oct 27, 2003Actual

First Submitted Date

Mar 23, 2012

First Submission Date that Met QC Criteria

Mar 27, 2012

First Posted Date

Mar 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2017

Last Update Posted Date

Feb 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: standard therapy Drug: placebo
Low dose	Experimental	Drug: standard therapy Drug: activated recombinant human factor VII
High dose	Experimental	Drug: standard therapy Drug: activated recombinant human factor VII

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard therapy	Drug	Standard treatment of bleeding	High dose Low dose Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect on bleeding, defined as change in bleeding score

Secondary Outcomes

Measure	Description	Time Frame
Transfusion requirements
Bleeding evaluation
Adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have undergone a hematopoietic 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Little Rock	Arkansas	72205	United States
Novo Nordisk Investigational Site

Label	URL
Clinical Trials at Novo Nordisk	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation