Acquired Bleeding DisorderPhase 2NCT01564563

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

A Phase 2 study testing standard therapy and activated recombinant human factor VII in people with Acquired Bleeding Disorder and Bleeding During/Following Surgery, run by Novo Nordisk A/S at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acquired Bleeding Disorder, Bleeding During/Following Surgery
What is being tested?: standard therapy and activated recombinant human factor VII
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 7 sitesUnited States
Study dates: 28 Jun 2002to 27 Oct 2003
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients who have undergone a hematopoietic stem cell transplantation

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Novo Nordisk Investigational Site
Baltimore, Maryland, 21231-1000
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599-7035
Novo Nordisk Investigational Site
Duarte, California, 91010
Novo Nordisk Investigational Site
Houston, Texas, 77030-4009
Novo Nordisk Investigational Site
Little Rock, Arkansas, 72205
Novo Nordisk Investigational Site
New York, New York, 10021
Novo Nordisk Investigational Site
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation (HSCT)

Conditions: Acquired Bleeding Disorder, Bleeding During/Following Surgery
Being tested: standard therapy, placebo, activated recombinant human factor VII

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

standard therapyDrug
Standard treatment of bleeding
placeboDrug
Placebo
activated recombinant human factor VIIDrug
Two days repeated treatment regimen - low dose administered i.v. (into the vein)
activated recombinant human factor VIIDrug
Two days repeated treatment regimen - high dose administered i.v. (into the vein)

Study groups in NCT01564563
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: standard therapy; Drug: placebo
Low dose	Experimental	Not described Receives: Drug: standard therapy; Drug: activated recombinant human factor VII
High dose	Experimental	Not described Receives: Drug: standard therapy; Drug: activated recombinant human factor VII

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect on bleeding, defined as change in bleeding score

Secondary outcomes (4)

Transfusion requirements
Bleeding evaluation
Adverse events
Changes in safety coagulation parameters

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 200227 Oct 2003

First posted28 Mar 2012 (estimated)
Study start28 Jun 2002
Primary completion27 Oct 2003
Study completion27 Oct 2003

Why it stopped: Trial enrollment was prematurely terminated due to excessively slow patient recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acquired Bleeding DisorderStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01564563
Sponsor's protocol ID: F7SCT-1485
Status last verified: Feb 2017
First submitted: 23 Mar 2012
Last updated: 27 Feb 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acquired Bleeding Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation (HSCT)
ClinicalTrials.gov ID: NCT01564563
Acronym / sponsor ID: F7SCT-1485
Conditions: Acquired Bleeding Disorder, Bleeding During/Following Surgery
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Trial enrollment was prematurely terminated due to excessively slow patient recruitment
Enrolment: 11 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 28 Jun 2002 (actual)
Primary completion: 27 Oct 2003 (actual)
Study completion: 27 Oct 2003 (actual)
First posted: 28 Mar 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Patients who have undergone a hematopoietic stem cell transplantation

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
standard therapyStandard treatment of bleeding	Drug	High dose, Low dose, Placebo
placeboPlacebo	Drug	Placebo
activated recombinant human factor VIITwo days repeated treatment regimen - low dose administered i.v. (into the vein)	Drug	Low dose
activated recombinant human factor VIITwo days repeated treatment regimen - high dose administered i.v. (into the vein)	Drug	High dose

Primary outcome

Effect on bleeding, defined as change in bleeding score

4 secondary outcomes

Transfusion requirements
Bleeding evaluation
Adverse events
Changes in safety coagulation parameters

Results and safety

The study was stopped early (reason given: Trial enrollment was prematurely terminated due to excessively slow patient recruitment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Acquired Bleeding Disorder

RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Acquired Fibrinogen Deficiency
RecruitingObservational study
Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
Trauma Induced Coagulopathy, Trauma Coagulopathy
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 3
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
Acquired Antithrombin Deficiency

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Trial enrollment was prematurely terminated due to excessively slow patient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on bleeding, defined as change in bleeding score. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01564563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.