Acquired Bleeding DisorderPhase 1NCT01153997
Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers
A Phase 1 study testing catridecacog in people with Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass, Healthy
- What is being tested?
- catridecacog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2010to Aug 2010
- 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 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram) and clinical laboratory data at screening, as judged by the physician
- Body mass index (BMI) between 18.0-27.0 kg/m2 (both inclusive)
Who cannot join
- The receipt of any investigational products for coagulation factor protein within 6 months prior to trial start (screening)
- Known or suspected allergy to yeast
- Known bleeding or hematologic disorder
- Significant history of alcoholism or drug/chemical abuse as judged by the physician or positive result in the alcohol breath test/screen of drugs at the trial start (screening)
- Smoking more than 10 cigarettes/day or equivalent
- Not able or willing to refrain from smoking whenever required for the trial procedures
Show all 11Show fewer
- Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the physician
- Excessive consumption of a diet deviating from a normal diet as judged by the physician
- Strenuous exercise as judged by the physician within 4 days prior to trial start (screening)
- Surgery or trauma with significant blood loss (500 mL or more blood) within 3 months prior to trial start (screening)
- Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods. Adequate contraceptive measures include that the subject uses a condom during intercourse or that the partner practices adequate conception (sterilisation, hormonal intrauterine devices and oral contraceptives).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo-controlled Single-dose, Parallel-group, Double-blind Trial Evaluating Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Japanese Subjects
This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated.
- Being tested
- catridecacog, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catridecacogDrug
Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
placeboDrug
Single rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
catridecacogDrug
Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
placeboDrug
Single rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: catridecacog |
| B | Experimental | Not described Receives: Drug: catridecacog |
| C | Placebo comparator | Not described Receives: Drug: placebo |
| D | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of serious adverse events
Measured: from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing
Occurrence of non-serious adverse events
Measured: from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing
Secondary outcomes (1)
AUC (area under the curve) from time zero to 28 days
Measured: at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT01153997
- Sponsor's protocol ID
- NN1810-3733
- Other IDs
- U1111-1114-8989, 101192
- Status last verified
- Jun 2014
- First submitted
- 29 Jun 2010
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled Single-dose, Parallel-group, Double-blind Trial Evaluating Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT01153997
- Acronym / sponsor ID
- NN1810-3733
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Jun 2010 (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 Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: catridecacog |
| B | Experimental | Drug: catridecacog |
| C | Placebo comparator | Drug: placebo |
| D | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram) and clinical laboratory data at screening, as judged by the physician
- Body mass index (BMI) between 18.0-27.0 kg/m2 (both inclusive)
Key exclusion criteria (11 listed)
- The receipt of any investigational products for coagulation factor protein within 6 months prior to trial start (screening)
- Known or suspected allergy to yeast
- Known bleeding or hematologic disorder
- Significant history of alcoholism or drug/chemical abuse as judged by the physician or positive result in the alcohol breath test/screen of drugs at the trial start (screening)
- Smoking more than 10 cigarettes/day or equivalent
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 |
|---|---|---|
| catridecacogSingle rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute. | Drug | A |
| placeboSingle rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute. | Drug | C |
| catridecacogSingle rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute. | Drug | B |
| placeboSingle rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute. | Drug | D |
Primary outcome
Occurrence of serious adverse events
Time frame: from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing
Occurrence of non-serious adverse events
Time frame: from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing
1 secondary outcome
AUC (area under the curve) from time zero to 28 days
Time frame: at day 28
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 18 Jun 2014.
- 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 catridecacog in people with Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Novo Nordisk A/S at 1 site in Japan.
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 18 Jun 2014. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
Occurrence of serious adverse events (time frame: from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing). The study lists 2 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 18 Jun 2014.