Congenital Bleeding DisorderPhase 1NCT01562587
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
A Phase 1 study testing activated recombinant human factor VII in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 8 sites in 5 countries.
Trial summary
This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state. Read more about this study
- Who is it for?
- Ages 3 to 55 years, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- What is being tested?
- activated recombinant human factor VII
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Sep 2002to May 2003
- Phase
- Phase 1
- 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 3 to 55 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
- Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors
Who cannot join
- Known hypersensitivity to activated recombinant human factor VII or any of its components
- Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
- Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
- Clinical manifestation of active/recent bleeding
- Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
- Body Mass Index (BMI) outside normal range
Show all 11Show fewer
- Known abuse of elicit drugs and/or alcohol
- Renal insufficiency
- Hepatic disease
- Cardiovascular disease
- Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Germany2 sites
Novo Nordisk Investigational Site
Bremen, 28205
Novo Nordisk Investigational Site
Frankfurt, 60590
Italy2 sites
Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Milan, 20124
United Kingdom2 sites
Novo Nordisk Investigational Site
London, WC1N 3JH
Novo Nordisk Investigational Site
Oxford, OX3 7LJ
About this study
Official title: Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non-Bleeding State
This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Being tested
- activated recombinant human factor VII
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
A single bolus dose is administered. Injected intravenously
activated recombinant human factor VIIDrug
A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously
| Study group | Role | What they receive |
|---|---|---|
| Adults | Experimental | Not described Receives: Drug: activated recombinant human factor VII |
| Paediatric | Experimental | Not described Receives: Drug: activated recombinant human factor VII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration curve from 0-12 hours
Secondary outcomes (7)
CL, the total body clearance
Cmax, the maximum concentration
tmax, the time to maximum concentration
t1/2, the terminal half-life
Area under the concentration curve from time 0-infinity
Vss, the apparent volume of distribution at steady state
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startSep 2002
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562587
- Sponsor's protocol ID
- F7HAEM-1503
- Status last verified
- Jan 2017
- First submitted
- 22 Mar 2012
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Villar A, Aronis S, Morfini M, Santagostino E, Auerswald G, Thomsen HF, Erhardtsen E, Giangrande PL. Pharmacokinetics of activated recombinant coagulation factor VII (NovoSeven) in children vs. adults with haemophilia A. Haemophilia. 2004 Jul;10(4):352-9. doi: 10.1111/j.1365-2516.2004.00925.x.
PubMed 15230949
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non-Bleeding State
- ClinicalTrials.gov ID
- NCT01562587
- Acronym / sponsor ID
- F7HAEM-1503
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 26 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.
This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | Experimental | Drug: activated recombinant human factor VII |
| Paediatric | Experimental | Drug: activated recombinant human factor VII |
Who may qualify
- Ages
- 3 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
- Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors
Key exclusion criteria (11 listed)
- Known hypersensitivity to activated recombinant human factor VII or any of its components
- Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
- Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
- Clinical manifestation of active/recent bleeding
- Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
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 |
|---|---|---|
| activated recombinant human factor VIIA single bolus dose is administered. Injected intravenously | Drug | Adults |
| activated recombinant human factor VIIA random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously | Drug | Paediatric |
Primary outcome
Area under the concentration curve from 0-12 hours
7 secondary outcomes
CL, the total body clearance
Cmax, the maximum concentration
tmax, the time to maximum concentration
t1/2, the terminal half-life
Area under the concentration curve from time 0-infinity
Vss, the apparent volume of distribution at steady state
Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Results publication: PubMed 15230949Villar A, Aronis S, Morfini M, Santagostino E, Auerswald G, Thomsen HF, Erhardtsen E, Giangrande PL. Pharmacokinetics of activated recombinant coagulation factor VII (NovoSeven) in children vs. adults with haemophilia A. Haemophilia. 2004 Jul;10(4):352-9. doi: 10.1111/j.1365-2516.2004.00925.x.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing activated recombinant human factor VII in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 8 sites in 5 countries.
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 2 inclusion and 11 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: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Italy, United Kingdom, Greece, Spain. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the concentration curve from 0-12 hours. 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 NCT01562587, which also lists 1 linked publication.
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 12 Jan 2017.