HealthyPhase 1NCT00612417
Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402
A Phase 1 study of Healthy, run by ThromboGenics at 1 site in Denmark.
Trial summary
Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Jun 2008
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males 18 to 45 years of age
- Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine
Who cannot join
- Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke
- History of important bleeding episodes
- Previous allergic reaction to immunoglobulin
- Present or previous history of severe allergy, for example asthma or anaphylactic reactions
- FVIII:C <50% or >150% at screening
- Clinically significant out of range values for any coagulation test during screening
- Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind and Placebo-controlled Study Investigating the Pharmacodynamic Effects of Administration of Recombinant Human Factor VIII in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402
Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402
- Conditions
- Healthy
- Being tested
- Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
- Keywords
- Interaction with recombinant FVIII
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402Drug
Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | recombinant FVIII Receives: Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402 |
| 2 | Placebo comparator | Placebo Receives: Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in coagulation parameters after rFVIII administration
Measured: To study end
Secondary outcomes (1)
PD of TB-402, safety of TB-402 alone and with rFVIII, PK of FVIII in rFVIII-treated subjects, changes in coagulation parameters after TB-402 administration
Measured: To study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB
- Responsible party
- Sponsor
- Investigators
- Thomas J Jensen, MD, PhD, Principal investigator, Cyncron CRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612417
- Sponsor's protocol ID
- TB-402-002
- Status last verified
- Apr 2014
- First submitted
- 28 Jan 2008
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind and Placebo-controlled Study Investigating the Pharmacodynamic Effects of Administration of Recombinant Human Factor VIII in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402
- ClinicalTrials.gov ID
- NCT00612417
- Acronym / sponsor ID
- TB-402-002
- Conditions
- Healthy
- Keywords
- Interaction with recombinant FVIII
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB
- Study start
- Jan 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Feb 2008 (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.
Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402recombinant FVIII |
| 2 | Placebo comparator | Drug: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males 18 to 45 years of age
- Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine
Key exclusion criteria (7 listed)
- Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke
- History of important bleeding episodes
- Previous allergic reaction to immunoglobulin
- Present or previous history of severe allergy, for example asthma or anaphylactic reactions
- FVIII:C <50% or >150% at 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 |
|---|---|---|
| Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402 | Drug | 1, 2 |
Primary outcome
Changes in coagulation parameters after rFVIII administration
Time frame: To study end
1 secondary outcome
PD of TB-402, safety of TB-402 alone and with rFVIII, PK of FVIII in rFVIII-treated subjects, changes in coagulation parameters after TB-402 administration
Time frame: To study end
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 7 Apr 2014.
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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.
Thomas J Jensen, MD, PhD principal investigator
Cyncron CRU
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 of Healthy, run by ThromboGenics at 1 site in Denmark.
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 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 Apr 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 Denmark. 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?
Changes in coagulation parameters after rFVIII administration (time frame: To study end). 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 7 Apr 2014.