Congenital Bleeding DisorderPhase 1NCT00922792
Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B
A Phase 1 study testing activated recombinant human factor VII, long acting in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 1 site in Spain.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia. Read more about this study
- Who is it for?
- Ages 18 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, long acting
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2009to Sep 2009
- 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 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Haemophilia A or B
- Bodyweight max 100 kg
- Body Mass Index (BMI) max 30 kg/m2
- Adequate venous access
Who cannot join
- Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
- The receipt of any investigational product within 30 days prior to enrolment in this trial
- Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
- The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
- Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
- Known pseudo tumours
Show all 12Show fewer
- Congenital or acquired coagulation disorders other than haemophilia A or B
- Any major and/or orthopaedic surgery within one month prior to trial start
- Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
- Clinical signs of renal dysfunction
- Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
- Use of non-prescribed opiate substances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Non-Randomised Single and Multiple Dose Trial Investigating the Safety and Pharmacokinetics of Intravenous Administration of Long Acting rFVIIa (LA-rFVIIa) in Patients With Haemophilia A and B
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Being tested
- activated recombinant human factor VII, long acting
- 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 VII, long actingDrug
Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration
activated recombinant human factor VII, long actingDrug
Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: activated recombinant human factor VII, long acting |
| B | Experimental | Not described Receives: Drug: activated recombinant human factor VII, long acting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Measured: after 1 and 2 weeks after dosing
Frequency of serious adverse events
Measured: after 1, 2 and 6-10 weeks after dosing
Frequency of MESIs (Medical Event of Special Interest)
Measured: after 1, 2 and 6-10 weeks after dosing
Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa
Measured: after 2 and 6-10 weeks after dosing
Secondary outcomes (1)
Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½
Measured: from time of dosing up to 72 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT00922792
- Sponsor's protocol ID
- NN7128-3700
- Other IDs
- 2009-010080-16, 2009
- Status last verified
- May 2016
- First submitted
- 16 Jun 2009
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-Randomised Single and Multiple Dose Trial Investigating the Safety and Pharmacokinetics of Intravenous Administration of Long Acting rFVIIa (LA-rFVIIa) in Patients With Haemophilia A and B
- ClinicalTrials.gov ID
- NCT00922792
- Acronym / sponsor ID
- NN7128-3700
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Jun 2009 (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 clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: activated recombinant human factor VII, long acting |
| B | Experimental | Drug: activated recombinant human factor VII, long acting |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Haemophilia A or B
- Bodyweight max 100 kg
- Body Mass Index (BMI) max 30 kg/m2
- Adequate venous access
Key exclusion criteria (12 listed)
- Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
- The receipt of any investigational product within 30 days prior to enrolment in this trial
- Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
- The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
- Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product 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 VII, long actingSingle dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration | Drug | A |
| activated recombinant human factor VII, long actingMultiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours | Drug | B |
Primary outcome
Frequency of adverse events
Time frame: after 1 and 2 weeks after dosing
Frequency of serious adverse events
Time frame: after 1, 2 and 6-10 weeks after dosing
Frequency of MESIs (Medical Event of Special Interest)
Time frame: after 1, 2 and 6-10 weeks after dosing
Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa
Time frame: after 2 and 6-10 weeks after dosing
1 secondary outcome
Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½
Time frame: from time of dosing up to 72 hours after the last dose
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 13 May 2016.
- 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
1 site in 1 country: 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, long acting in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 1 site in Spain.
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 12 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Frequency of adverse events (time frame: after 1 and 2 weeks after dosing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2016.