Congenital Bleeding DisorderPhase 1NCT01692925
Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A
A Phase 1 study testing turoctocog alfa in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 5 sites in 4 countries.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A
- What is being tested?
- turoctocog alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Dec 2012to Mar 2013
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male subjects with the diagnosis of severe haemophilia A (FVIII<1%) from age 18 years
- Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
- Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count >200/microL)
Who cannot join
- Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
- History of FVIII inhibitors
- Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
- Known or suspected allergy to trial product (FVIII) or related products
- Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
- Body mass index (BMI) above 30 kg/m^2
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
Novo Nordisk Investigational Site
Berlin, 10249
Novo Nordisk Investigational Site
Frankfurt/M., 60590
About this study
Official title: Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Being tested
- turoctocog alfa
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
turoctocog alfaDrug
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
turoctocog alfaDrug
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
| Study group | Role | What they receive |
|---|---|---|
| Lot A | Experimental | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. Receives: Drug: turoctocog alfa |
| Lot B | Experimental | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. Receives: Drug: turoctocog alfa |
| Lot C | Experimental | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. Receives: Drug: turoctocog alfa |
| Lot D | Experimental | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. Receives: Drug: turoctocog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay
Measured: up to 48 hours after i.v. administration
Secondary outcomes (6)
Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay
Measured: up to 48 hours after i.v. administration
Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])
Measured: up to 48 hours after i.v. administration
Area under the FVIII activity-time curve (AUC)
Measured: up to 48 hours after i.v. administration
Terminal half-life of FVIII (t½)
Measured: up to 48 hours after i.v. administration
Clearance of FVIII (CL)
Measured: up to 48 hours after i.v. administration
Incidence of adverse events (AEs) including FVIII inhibitors
Measured: After approximately 3 months (at end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT01692925
- Sponsor's protocol ID
- NN7008-4015
- Other IDs
- 2012-001444-21, U1111-1129-1517
- Status last verified
- Feb 2017
- First submitted
- 21 Sep 2012
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13.
PubMed 25495795
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A
- ClinicalTrials.gov ID
- NCT01692925
- Acronym / sponsor ID
- NN7008-4015
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Sep 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 the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lot A | Experimental | Drug: turoctocog alfaEach subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
| Lot B | Experimental | Drug: turoctocog alfaEach subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
| Lot C | Experimental | Drug: turoctocog alfaEach subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
| Lot D | Experimental | Drug: turoctocog alfaEach subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male subjects with the diagnosis of severe haemophilia A (FVIII<1%) from age 18 years
- Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
- Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count >200/microL)
Key exclusion criteria (6 listed)
- Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
- History of FVIII inhibitors
- Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
- Known or suspected allergy to trial product (FVIII) or related products
- Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
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 |
|---|---|---|
| turoctocog alfaTrial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection. | Drug | Lot A, Lot B, Lot C |
| turoctocog alfaTrial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection. | Drug | Lot D |
Primary outcome
Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay
Time frame: up to 48 hours after i.v. administration
6 secondary outcomes
Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay
Time frame: up to 48 hours after i.v. administration
Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])
Time frame: up to 48 hours after i.v. administration
Area under the FVIII activity-time curve (AUC)
Time frame: up to 48 hours after i.v. administration
Terminal half-life of FVIII (t½)
Time frame: up to 48 hours after i.v. administration
Clearance of FVIII (CL)
Time frame: up to 48 hours after i.v. administration
Incidence of adverse events (AEs) including FVIII inhibitors
Time frame: After approximately 3 months (at end of trial)
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 10 Feb 2017.
- Results publication: PubMed 25495795Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Congenital Bleeding Disorder
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing turoctocog alfa in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 5 sites in 4 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 4 inclusion and 6 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 10 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 5 sites in Germany, Latvia, Malaysia, 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?
Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay (time frame: up to 48 hours after i.v. administration). 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 NCT01692925, 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 10 Feb 2017.