Congenital Bleeding DisorderPhase 2NCT00486278
Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
A Phase 2 study testing eptacog alfa (activated) and vatreptacog alfa (activated) in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 45 sites in 18 countries.
Trial summary
This trial is conducted in Africa, Asia, Europe, Japan, and North and South America. The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors. Read more about this study
- Who is it for?
- Ages 12 years and older, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- What is being tested?
- eptacog alfa (activated) and vatreptacog alfa (activated)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 45 sitesin 18 countries
- Study dates
- Jun 2007to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older (at least 18 years in Croatia, France and United Kingdom (UK))
- Clinical diagnosis of congenital haemophilia A or B with a current positive inhibitor titre and a known peak inhibitor of above 5 Bethesda units (BU) (present or in the past) to human FVIII or IX and known antihuman FVIII or IX anamnestic response
- Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds (hemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 12 months at trial entry
Who cannot join
- Known allergy to rFVIIa, and/or suspected allergy to trial product
- Platelet count lower than 50,000 mm^3 based on medical records at trial entry (visit 1)
- Any clinical signs or history of thromboembolic events
- Advanced atherosclerotic disease
- Severe liver disease based on medical records within the past 12 months at trial entry (Visit 1), as defined by alanine aminotransferase (ALAT) above 3 times the upper limit of normal reference range
- Known active pseudo tumours (documented bleeding requiring treatment within the last 3 months
- Subject had any (major) surgical procedure in the 30 days prior to screening into the trial. a. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject
Trial locations and contacts
45 sites in 18 countries.
45 sites in 18 countries
United States12 sites
Novo Nordisk Investigational Site
Ann Arbor, Michigan, 48109-5235
Novo Nordisk Investigational Site
Augusta, Georgia, 30912
Novo Nordisk Investigational Site
Boston, Massachusetts, 02115
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599-7035
Novo Nordisk Investigational Site
Chicago, Illinois, 60612-3833
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45229
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46260
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242
Novo Nordisk Investigational Site
Los Angeles, California, 90027
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55455
Novo Nordisk Investigational Site
New York, New York, 10029
Novo Nordisk Investigational Site
Portland, Oregon, 97239-3011
Japan5 sites
Novo Nordisk Investigational Site
Hiroshima-shi, Hiroshima, 734 8551
Novo Nordisk Investigational Site
Itabashi-ku, Tokyo, 173 8606
Novo Nordisk Investigational Site
Kashihara-shi, Nara, 634 8522
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, 466 8560
Novo Nordisk Investigational Site
Nishinomiya-shi, 663 8051
Turkey (Türkiye)4 sites
Novo Nordisk Investigational Site
Adana, 01130
Novo Nordisk Investigational Site
Ankara, 06100
Novo Nordisk Investigational Site
Antalya, 01010
Novo Nordisk Investigational Site
Bornova-IZMIR, 35100
Brazil3 sites
Novo Nordisk Investigational Site
Campinas, São Paulo, 13081970
Novo Nordisk Investigational Site
Rio de Janeiro, Rio de Janeiro, 20211-030
Novo Nordisk Investigational Site
São Paulo, 04024-002
Italy3 sites
Novo Nordisk Investigational Site
Castelfranco Veneto, 31033
Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Milan, 20124
South Africa3 sites
Novo Nordisk Investigational Site
Cape Town, 7925
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4013
Novo Nordisk Investigational Site
Parktown Johannesburg, Gauteng, 2193
Hungary2 sites
Novo Nordisk Investigational Site
Budapest, H-1134
Novo Nordisk Investigational Site
Debrecen, 4012
Taiwan2 sites
Novo Nordisk Investigational Site
Changhua, 500
Novo Nordisk Investigational Site
Taipei, 100
United Kingdom2 sites
Novo Nordisk Investigational Site
London, SE1 7EH
Novo Nordisk Investigational Site
Manchester, M13 9WL
Argentina1 site
Novo Nordisk Investigational Site
Ciudad Autónoma de Bs. As., C1425ASU
About this study
Official title: A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors
This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.
The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Being tested
- eptacog alfa (activated), vatreptacog alfa (activated)
- 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.
eptacog alfa (activated)Drug
90 mcg/kg, injected i.v.
vatreptacog alfa (activated)Drug
5 mcg/kg, injected i.v.
vatreptacog alfa (activated)Drug
10 mcg/kg, injected i.v.
vatreptacog alfa (activated)Drug
20 mcg/kg, injected i.v.
vatreptacog alfa (activated)Drug
40 mcg/kg, injected i.v.
vatreptacog alfa (activated)Drug
80 mcg/kg, injected i.v.
| Study group | Role | What they receive |
|---|---|---|
| vatreptacog alfa 5 mcg/kg | Experimental | Not described Receives: Drug: vatreptacog alfa (activated) |
| vatreptacog alfa 10 mcg/kg | Experimental | Not described Receives: Drug: vatreptacog alfa (activated) |
| vatreptacog alfa 20 mcg/kg | Experimental | Not described Receives: Drug: vatreptacog alfa (activated) |
| vatreptacog alfa 40 mcg/kg | Experimental | Not described Receives: Drug: vatreptacog alfa (activated) |
| vatreptacog alfa 80 mcg/kg | Experimental | Not described Receives: Drug: vatreptacog alfa (activated) |
| rFVIIa 90 mcg/kg | Experimental | Not described Receives: Drug: eptacog alfa (activated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs)
Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.
Secondary outcomes (20)
Activated Recombinant Human Factor VII Analogue Activity in the Blood
Measured: 0-24 hours after trial product administration
Prothrombin Time (PT)
The test measures the clotting time of plasma following the activation of tissue factor (TF also called thromboplastin) and calcium to hypocalcemic plasma. PT was provided in percent based on the measured PT in seconds and related/converted with the relevant standard curve. The percent value was derived based on the hyperbolic relation between PT (sec) and % PT activity.
Measured: pre-dose - 12 hours after trial product administration
F1 + 2 (Prothrombin Fragments 1+2)
Thrombin and F1+2 are formed in equimolar quantities by the enzymatic cleavage of prothrombin (FII), and F1+2 thus indicate that thrombin has been generated.
Measured: pre-dose - 12 hours after trial product administration
Activated Partial Thromboplastin Time (aPTT)
The aPTT time measured in clinical samples reflects both the effect of the drugs (generation of thrombin and FXa) and the presence of rFVIIa /rFVIIa analogue in the plasma samples causing a dose dependent shortening of the clotting time.
Measured: pre-dose - 12 hours after trial product administration
Cessation of Bleeding: Number of Doses Needed to Control Bleeding
Measured: Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure)
Number of Subjects With Need for Additional Haemostatic Agents
Measured: within 24 hours after successful control of bleeding episode with trial product
Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) )
Measured: 0-24 hours after trial product administration
Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity)
Measured: 0-24 hours after trial product administration
Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time)
Measured: 0-24 hours after trial product administration
Pharmacokinetic Parameters Based on FVIIa Activity: t½ (Terminal Half-life)
Measured: 0-24 hours after trial product administration
Pharmacokinetic Parameters Based on FVIIa Activity: CL (Total Clearance)
Measured: 0-24 hours after trial product administration
Pharmakokinetic Parameters Based on FVIIa Activity: Vss (Distribution Volume at Steady State)
Measured: 0-24 hours after trial product administration
Immunogenicity (Inhibitor Development)
Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or rFVIIa.
Measured: Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.
Biochemistry: ALAT (Alanine Aminotransferase)
Measured: screening visit, pre-dose and 12 hours after dosing
Biochemistry: Creatinine
Measured: screening visit, pre-dose and 12 hours after dosing
Haematology: Haemoglobin
Measured: screening visit, pre-dose and 12 hours after dosing
Haematology: Red Cell Count
Measured: screening visit, pre-dose and 12 hours after dosing
Haematology: Packed Cell Volume
Measured: screening visit, pre-dose and 12 hours after dosing
Haematology: White Cell Count
Measured: screening visit, pre-dose and 12 hours after dosing
Haematology: Platelet Count
Measured: screening visit, pre-dose and 12 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 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
- NCT00486278
- Sponsor's protocol ID
- NN1731-1804
- Other IDs
- 2006-004879-35, CTI-080612
- Status last verified
- Jan 2017
- First submitted
- 13 Jun 2007
- Last updated
- 7 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
de Paula EV, Kavakli K, Mahlangu J, Ayob Y, Lentz SR, Morfini M, Nemes L, Salek SZ, Shima M, Windyga J, Ehrenforth S, Chuansumrit A; 1804 (adept(TM)1) Investigators. Recombinant factor VIIa analog (vatreptacog alfa [activated]) for treatment of joint bleeds in hemophilia patients with inhibitors: a randomized controlled trial. J Thromb Haemost. 2012 Jan;10(1):81-9. doi: 10.1111/j.1538-7836.2011.04549.x.
PubMed 22470921
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors
- ClinicalTrials.gov ID
- NCT00486278
- Acronym / sponsor ID
- NN1731-1804
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Jun 2007 (estimated)
- Results
- Posted 25 Dec 2014
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 Africa, Asia, Europe, Japan, and North and South America.
The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| vatreptacog alfa 5 mcg/kg | Experimental | Drug: vatreptacog alfa (activated) |
| vatreptacog alfa 10 mcg/kg | Experimental | Drug: vatreptacog alfa (activated) |
| vatreptacog alfa 20 mcg/kg | Experimental | Drug: vatreptacog alfa (activated) |
| vatreptacog alfa 40 mcg/kg | Experimental | Drug: vatreptacog alfa (activated) |
| vatreptacog alfa 80 mcg/kg | Experimental | Drug: vatreptacog alfa (activated) |
| rFVIIa 90 mcg/kg | Experimental | Drug: eptacog alfa (activated) |
Who may qualify
- Ages
- 12 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 12 years of age or older (at least 18 years in Croatia, France and United Kingdom (UK))
- Clinical diagnosis of congenital haemophilia A or B with a current positive inhibitor titre and a known peak inhibitor of above 5 Bethesda units (BU) (present or in the past) to human FVIII or IX and known antihuman FVIII or IX anamnestic response
- Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds (hemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 12 months at trial entry
Key exclusion criteria (7 listed)
- Known allergy to rFVIIa, and/or suspected allergy to trial product
- Platelet count lower than 50,000 mm^3 based on medical records at trial entry (visit 1)
- Any clinical signs or history of thromboembolic events
- Advanced atherosclerotic disease
- Severe liver disease based on medical records within the past 12 months at trial entry (Visit 1), as defined by alanine aminotransferase (ALAT) above 3 times the upper limit of normal reference range
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 |
|---|---|---|
| eptacog alfa (activated)90 mcg/kg, injected i.v. | Drug | rFVIIa 90 mcg/kg |
| vatreptacog alfa (activated)5 mcg/kg, injected i.v. | Drug | vatreptacog alfa 5 mcg/kg |
| vatreptacog alfa (activated)10 mcg/kg, injected i.v. | Drug | vatreptacog alfa 10 mcg/kg |
| vatreptacog alfa (activated)20 mcg/kg, injected i.v. | Drug | vatreptacog alfa 20 mcg/kg |
| vatreptacog alfa (activated)40 mcg/kg, injected i.v. | Drug | vatreptacog alfa 40 mcg/kg |
| vatreptacog alfa (activated)80 mcg/kg, injected i.v. | Drug | vatreptacog alfa 80 mcg/kg |
Primary outcome
Number of Adverse Events (AEs)
Time frame: Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.
Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
20 secondary outcomes
Activated Recombinant Human Factor VII Analogue Activity in the Blood
Time frame: 0-24 hours after trial product administration
Prothrombin Time (PT)
Time frame: pre-dose - 12 hours after trial product administration
F1 + 2 (Prothrombin Fragments 1+2)
Time frame: pre-dose - 12 hours after trial product administration
Activated Partial Thromboplastin Time (aPTT)
Time frame: pre-dose - 12 hours after trial product administration
Cessation of Bleeding: Number of Doses Needed to Control Bleeding
Time frame: Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure)
Number of Subjects With Need for Additional Haemostatic Agents
Time frame: within 24 hours after successful control of bleeding episode with trial product
Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) )
Time frame: 0-24 hours after trial product administration
Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity)
Time frame: 0-24 hours after trial product administration
Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time)
Time frame: 0-24 hours after trial product administration
Pharmacokinetic Parameters Based on FVIIa Activity: t½ (Terminal Half-life)
Time frame: 0-24 hours after trial product administration
Pharmacokinetic Parameters Based on FVIIa Activity: CL (Total Clearance)
Time frame: 0-24 hours after trial product administration
Pharmakokinetic Parameters Based on FVIIa Activity: Vss (Distribution Volume at Steady State)
Time frame: 0-24 hours after trial product administration
Immunogenicity (Inhibitor Development)
Time frame: Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.
Biochemistry: ALAT (Alanine Aminotransferase)
Time frame: screening visit, pre-dose and 12 hours after dosing
Biochemistry: Creatinine
Time frame: screening visit, pre-dose and 12 hours after dosing
Haematology: Haemoglobin
Time frame: screening visit, pre-dose and 12 hours after dosing
Haematology: Red Cell Count
Time frame: screening visit, pre-dose and 12 hours after dosing
Haematology: Packed Cell Volume
Time frame: screening visit, pre-dose and 12 hours after dosing
Haematology: White Cell Count
Time frame: screening visit, pre-dose and 12 hours after dosing
Haematology: Platelet Count
Time frame: screening visit, pre-dose and 12 hours after dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22470921de Paula EV, Kavakli K, Mahlangu J, Ayob Y, Lentz SR, Morfini M, Nemes L, Salek SZ, Shima M, Windyga J, Ehrenforth S, Chuansumrit A; 1804 (adept(TM)1) Investigators. Recombinant factor VIIa analog (vatreptacog alfa [activated]) for treatment of joint bleeds in hemophilia patients with inhibitors: a randomized controlled trial. J Thromb Haemost. 2012 Jan;10(1):81-9. doi: 10.1111/j.1538-7836.2011.04549.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
45 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eptacog alfa (activated) and vatreptacog alfa (activated) in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 45 sites in 18 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 3 inclusion and 7 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Japan, Turkey (Türkiye), Brazil, Italy and 13 more countries. 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 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?
Yes. Results are posted in the registry (first posted 25 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Adverse Events (AEs) (time frame: Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.). 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 NCT00486278, 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 7 Mar 2017.