Congenital Bleeding DisorderPhase 1NCT01288391
Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients
A Phase 1 study testing NNC 0128-0000-2011 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 3 sites in 3 countries.
Trial summary
This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients. 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, Haemophilia B
- What is being tested?
- NNC 0128-0000-2011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2011to Jul 2011
- 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
- Patients diagnosed with haemophilia A or B (with or without inhibitors and irrespective of severity) based on medical records
- Japan: A legally acceptable representative (LAR) is required for patients between 18 and 19 years
- Body weight less than or equal to 100.0 kg
- Body Mass Index (BMI) less than or equal to 30.0 kg/m^2
Who cannot join
- Known or suspected allergy to trial product(s) or related products (including rFVIIa)
- Previous participation in this trial defined as administration of trial product
- The receipt of any investigational product within 30 days prior to trial start (screening)
- Congenital or acquired coagulation disorders other than haemophilia A or B
- Receipt of Immune Tolerance Induction (ITI) within the last 30 days prior to screening
- Any surgery within 30 days prior to screening
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- Planned surgery within the trial period
- Platelet count below 50,000 platelets/mcL (based on medical records within the last 1 month or laboratory results at screening)
- Prothrombin time (PT) above 4 times Upper limit of normal (ULN) or International normalised ratio (INR) greater than 1.7
- Hepatic dysfunction or severe hepatic disease as evaluated by the investigator (trial physician)
- Renal dysfunction (dialysis) and/or creatinine levels more than or equal to 20% above upper normal limit (according to medical records or laboratory results at screening)
- Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
- Any disease, condition, or medication which, according to the investigator's (trial physician) judgement, could imply a potential hazard to the patient or interfere with the trial participation or trial outcome
- Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: An Open Non-randomised Dose Escalation Trial Investigating the Safety and Pharmacokinetics of Single Intravenous Administrations of NNC128-0000-2011 in Patients With Haemophilia A or B
This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Being tested
- NNC 0128-0000-2011
- 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.
NNC 0128-0000-2011Drug
Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
NNC 0128-0000-2011Drug
Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
| Study group | Role | What they receive |
|---|---|---|
| 100 mcg/kg | Experimental | Not described Receives: Drug: NNC 0128-0000-2011 |
| 200 mcg/kg | Experimental | Not described Receives: Drug: NNC 0128-0000-2011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs)
Measured: from first trial product administration until 12 weeks after last trial product administration
Frequency of serious adverse events (SAEs)
Measured: from first trial product administration until 12 weeks after last trial product administration
Frequency of MESIs (Medical Event of Special Interest)
Measured: from first trial product administration until 12 weeks after last trial product administration
Secondary outcomes (1)
Neutralising antibodies against FVIIa and/or N7-GP
Measured: from first trial product administration until 12 weeks after last trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
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
- Single group
- 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
- NCT01288391
- Sponsor's protocol ID
- NN7128-3840
- Other IDs
- 2010-021127-28, U1111-1118-6995, JapicCTI-111455
- Status last verified
- May 2016
- First submitted
- 1 Feb 2011
- 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 Dose Escalation Trial Investigating the Safety and Pharmacokinetics of Single Intravenous Administrations of NNC128-0000-2011 in Patients With Haemophilia A or B
- ClinicalTrials.gov ID
- NCT01288391
- Acronym / sponsor ID
- NN7128-3840
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Feb 2011 (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 and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 mcg/kg | Experimental | Drug: NNC 0128-0000-2011 |
| 200 mcg/kg | Experimental | Drug: NNC 0128-0000-2011 |
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)
- Patients diagnosed with haemophilia A or B (with or without inhibitors and irrespective of severity) based on medical records
- Japan: A legally acceptable representative (LAR) is required for patients between 18 and 19 years
- Body weight less than or equal to 100.0 kg
- Body Mass Index (BMI) less than or equal to 30.0 kg/m^2
Key exclusion criteria (14 listed)
- Known or suspected allergy to trial product(s) or related products (including rFVIIa)
- Previous participation in this trial defined as administration of trial product
- The receipt of any investigational product within 30 days prior to trial start (screening)
- Congenital or acquired coagulation disorders other than haemophilia A or B
- Receipt of Immune Tolerance Induction (ITI) within the last 30 days prior to screening
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 |
|---|---|---|
| NNC 0128-0000-2011Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously) | Drug | 100 mcg/kg |
| NNC 0128-0000-2011Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously) | Drug | 200 mcg/kg |
Primary outcome
Frequency of Adverse Events (AEs)
Time frame: from first trial product administration until 12 weeks after last trial product administration
Frequency of serious adverse events (SAEs)
Time frame: from first trial product administration until 12 weeks after last trial product administration
Frequency of MESIs (Medical Event of Special Interest)
Time frame: from first trial product administration until 12 weeks after last trial product administration
1 secondary outcome
Neutralising antibodies against FVIIa and/or N7-GP
Time frame: from first trial product administration until 12 weeks after last trial product administration
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC 0128-0000-2011 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 3 sites in 3 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 14 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 3 sites in Germany, Japan, 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 (AEs) (time frame: from first trial product administration until 12 weeks after last trial product administration). The study lists 3 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.