Hemophilia A With InhibitorsPhase 2/3NCT02484638
Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors
A Phase 2/3 study testing CSL689 and Eptacog alfa (activated) in people with Hemophilia A With Inhibitors and Hemophilia B With Inhibitors, run by CSL Behring at 10 sites in 9 countries.
Trial summary
The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety of rVIIa-FP (CSL689). The study will enroll approximately 54 male subjects, 12 to 65 years of age, with hemophilia types A or B who have developed inhibitors to FVIII or FIX. Read more about this study
- Who is it for?
- Ages 12 to 65 years, men only
- Conditions the study is for
- Hemophilia A With Inhibitors, Hemophilia B With Inhibitors
- What is being tested?
- CSL689 and Eptacog alfa (activated)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesin 9 countries
- Study dates
- 23 Jul 2015to 28 Mar 2018
- Phase
- Phase 2/3
- 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 12 to 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male subjects with hemophilia A or B and inhibitors.
- Age ≥ 12 and ≤ 65 years.
- High responding inhibitor with documented historical inhibitor titer > 5 Bethesda Units/mL.
Who cannot join
- Congenital or acquired coagulation disorders other than hemophilia A or B.
- Ongoing immune tolerance induction therapy or planned during study.
- Known or suspected hypersensitivity to activated recombinant human FVII or to any excipient of CSL689.
- Body mass index > 30 kg/m².
- Major surgery within 28 days before screening or scheduled major and / or orthopedic surgery during the study.
- Advanced atherosclerotic disease (ie, known history of ischemic heart disease, or ischemic stroke).
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- Any clinical signs or known history of thromboembolic events, including known deep vein thrombosis.
- Human immunodeficiency virus (HIV)-positive subjects who have low cluster of differentiation 4 (CD4)+ lymphocyte count (200/μL or less) at screening.
- Use of the following within the screening period or planned during study: a) plasma or coagulation factor concentrates other than rescue therapy or therapy during Part 1, b) other platelet inhibitors, c) desmopressin, and d) fibrinolysis inhibitors, except if used as local treatment (eg, for oral bleeds).
Trial locations and contacts
10 sites in 9 countries.
10 sites in 9 countries
Thailand2 sites
Site Reference # 7640006
Bangkok, 10400
Site Reference # 7640004
Khon Kaen, 40002
About this study
Official title: A Multicenter, Open-label, Multiple-dose, Dose Escalation Study to Investigate the Pharmacokinetics, Efficacy, and Safety of rVIIa-FP (CSL 689) in Subjects With Hemophilia (A or B) and Inhibitors
The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety of rVIIa-FP (CSL689). The study will enroll approximately 54 male subjects, 12 to 65 years of age, with hemophilia types A or B who have developed inhibitors to FVIII or FIX. The study consists of 3 sequential parts (Parts 1, 2, 3): The purpose of Part 1 (PK part) is to evaluate the PK of a single treatment of CSL689 (low dose or high dose) and compare with the PK of a single treatment of Eptacog alfa (low dose or high dose). In Part 1, CSL689 and Eptacog alfa will be given by the doctor at the study center. The purpose of Part 2 (Dose-evaluation part) is to identify which of the 2 tested dose levels of CSL689 shows the best efficacy and safety in stopping acute bleeding events (this dose will be called the "population best dose"). The purpose of the final Part 3 (Repeated-dose part) is to confirm the efficacy and safety of the "population best dose" identified in Part 2. In Parts 2 and 3, subjects will self-administer a specified number of CSL689 infusions at home on-demand (ie, when a bleeding event occurs), will keep an electronic diary, and will visit the center at monthly intervals. This study is expected to last for up to 16 months for the subjects participating in all 3 parts, and up to 9 months for the subjects participating in Part 3 only.
- Being tested
- CSL689, Eptacog alfa (activated)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL689Drug
Recombinant fusion protein, linking activated coagulation factor VII with albumin. Two dose levels (low dose, high dose) will be studied in Parts 1, 2, and 3.
Eptacog alfa (activated)Drug
Recombinant activated coagulation factor VII. Two dose levels (low dose, high dose) will be studied in Part 1.
| Study group | Role | What they receive |
|---|---|---|
| CSL689 low-dose | Experimental | * Part 1: single injection of low-dose CSL689 for PK evaluation
* Part 2: up to 2 injections of low-dose CSL689 per bleeding event (bleeding events 1 to 3*)
* Part 3: up to 3 injections of low-dose CSL689 per bleeding event * Note: All subjects in the low-dose arm will be treated with high-dose CSL689 for bleeding events 4-6 in Part 2 Receives: Drug: CSL689 |
| CSL689 high-dose | Experimental | * Part 1: single injection of high-dose CSL689 for PK evaluation
* Part 2: up to 2 injections of high-dose CSL689 per bleeding event (bleeding events 4 to 6*)
* Part 3: up to 3 injections of high-dose CSL689 per bleeding event
* Note: All subjects in the high-dose arm will be treated with low-dose CSL689 for bleeding events 1-3 in Part 2 Receives: Drug: CSL689 |
| Eptacog alfa low-dose | Active comparator | Single injection of low-dose Eptacog alfa in Part 1 for PK evaluation Receives: Drug: Eptacog alfa (activated) |
| Eptacog alfa high-dose | Active comparator | Single injection of high-dose Eptacog alfa in Part 1 for PK evaluation Receives: Drug: Eptacog alfa (activated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC0-t)
Area under plasma factor VIIa activity versus time curve from time 0 to last sample with quantifiable activity (in Part 1 only).
Measured: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Incremental recovery
Incremental recovery of plasma factor VIIa activity (in Part 1 only)
Measured: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Elimination half-life
Elimination half-life of plasma factor VIIa activity (in Part 1 only)
Measured: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Total clearance
Total clearance of plasma factor VIIa activity (in Part 1 only)
Measured: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Treatment success with first CSL689 injection
Percentage of bleeding events successfully treated with the first injection of CSL689 for each bleeding event in Part 2.
Measured: Up to 8 hours after first CSL689 injection for each bleeding event
Treatment success with first CSL689 injection at the population best dose
Percentage of bleeding events successfully treated with the first injection of the population best dose of CSL689 in subjects participating only in Part 3, along with its 95% confidence interval
Measured: Up to 8 hours after first CSL689 injection for each bleeding event
Treatment success with first or second CSL689 injection at the population best dose
Percentage of bleeding events successfully treated with the first or second injection of the population best dose of CSL689 in subjects participating in Part 3 only, along with its 95% confidence interval
Measured: Up to 16 hours after first CSL689 injection for each bleeding event
Secondary outcomes (22)
Treatment success with first or second CSL689 injection
Percentage of bleeding events successfully treated with the first or second (if required) injection of CSL689 for each bleeding event in Part 2.
Measured: Up to 16 hours after first CSL689 injection for each bleeding event
Number of bleeding events requiring > 1 CSL689 injection
Outcome measure will be analyzed for Part 2 and for Part 3
Measured: Up to 8 hours after first CSL689 injection for each bleeding event
Number of CSL689 injections per bleeding event
Outcome measure will be analyzed for Part 2 and for Part 3
Measured: Up to 16 hours (Part 2) or up to 24 hours (Part 3) after first CSL689 injection for each bleeding event
Total dose of CSL689 per bleeding event
Outcome measure will be analyzed for Part 2 and for Part 3
Measured: Up to 16 hours (Part 2) or up to 24 hours (Part 3) after first CSL689 injection for each bleeding event
Treatment success with first CSL689 injection at the population best dose
Percentage of bleeding events successfully treated with the first injection of CSL689 for each bleeding event at the population best dose in subjects participating in Part 3
Measured: Up to 8 hours after first CSL689 injection for each bleeding event
Percentage of first bleeding events successfully treated with first CSL689 injection at population best dose in Part 3
Measured: Up to 8 hours after first CSL689 injection for first bleeding event
Treatment success at population best dose
Percentage of bleeding events successfully treated with the:
- first or second injection
- first, second or third injection of the population best dose of CSL689 in Part 3
Measured: Up to 24 hours after first CSL689 injection for each bleeding event
Treatment success with CSL689 at the dose level that is not the population best dose
Percentage of bleeding events successfully treated with the:
- first injection
- first or second injection
- first, second or third injection at the dose level that is not the population best dose of CSL689 in Part 3
Measured: Up to 24 hours after first CSL689 injection for each bleeding event
Percentage of bleeding events with only "definite" or "abrupt" subject-reported pain relief at the population best dose
Measured: Up to 24 hours after CSL689 injection for each bleeding event
Percentage of bleeding events with "good" or "excellent" investigator-reported assessment of treatment response at the population best dose of CSL689
Measured: Up to 9 months
Proportion of recurrences
Recurrence defined as a bleeding in the same joint/anatomical location within 24 hours after an initial "good" or "excellent" response.
Measured: Up to 9 months
Proportion of bleeding events with ultrarapid progression.
"Ultrarapid progression" is defined as overt, uncontrolled hemorrhage and / or progressive increase in pain and / or rapid progression in hematoma size
Measured: Up to 9 months
Proportion of bleeding events requiring post-hemostatic maintenance dosing
Measured: Up to 9 months
Number of subjects with treatment-emergent adverse events (TEAEs)
TEAEs are adverse events (AEs) that start on or after the date and time of the first injection of either CSL689 or Eptacog alfa.
Number of subjects with TEAEs will be presented:
- Overall
- Related to CSL689
Measured: Up to 16 months
Percentage of subjects with TEAEs
TEAEs are AEs that start on or after the date and time of the first injection of either CSL689 or Eptacog alfa.
Percentage of subjects with TEAEs will be presented:
- Overall
- Related to CSL689
Measured: Up to 16 months
Number of subjects with an antibody response
Number of subjects with:
- Inhibitors against FVII
- Antibodies to CSL689
Measured: Up to 16 months
Percentage of subjects with an antibody response
Percentage of subjects with:
- Inhibitors against FVII
- Antibodies to CSL689
Measured: Up to 16 months
AUC(0-inf)
Area under plasma factor VIIa activity versus time curve from time 0 extrapolated to infinity
Measured: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Maximum observed plasma FVIIa activity (Cmax)
Measured: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Time of occurrence of maximum observed plasma FVIIa activity (Tmax)
Measured: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Volume of distribution at steady state (Vss)
Measured: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Mean residence time (MRT)
Measured: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start23 Jul 2015
- Primary completion28 Mar 2018
- Study completion28 Mar 2018
Why it stopped: Business decision non-safety related.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia A With InhibitorsStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Physician, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484638
- Sponsor's protocol ID
- CSL689_2001
- Other IDs
- 2012-001309-26
- Status last verified
- Aug 2019
- First submitted
- 25 Jun 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Multiple-dose, Dose Escalation Study to Investigate the Pharmacokinetics, Efficacy, and Safety of rVIIa-FP (CSL 689) in Subjects With Hemophilia (A or B) and Inhibitors
- ClinicalTrials.gov ID
- NCT02484638
- Acronym / sponsor ID
- CSL689_2001
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision non-safety related.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2015 (actual)
- Primary completion
- 28 Mar 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 29 Jun 2015 (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.
The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety of rVIIa-FP (CSL689). The study will enroll approximately 54 male subjects, 12 to 65 years of age, with hemophilia types A or B who have developed inhibitors to FVIII or FIX. The study consists of 3 sequential parts (Parts 1, 2, 3): The purpose of Part 1 (PK part) is to evaluate the PK of a single treatment of CSL689 (low dose or high dose) and compare with the PK of a single treatment of Eptacog alfa (low dose or high dose). In Part 1, CSL689 and Eptacog alfa will be given by the doctor at the study center. The purpose of Part 2 (Dose-evaluation part) is to identify which of the 2 tested dose levels of CSL689 shows the best efficacy and safety in stopping acute bleeding events (this dose will be called the "population best dose"). The purpose of the final Part 3 (Repeated-dose part) is to confirm the efficacy and safety of the "population best dose" identified in Part 2. In Parts 2 and 3, subjects will self-administer a specified number of CSL689 infusions at home on-demand (ie, when a bleeding event occurs), will keep an electronic diary, and will visit the center at monthly intervals. This study is expected to last for up to 16 months for the subjects participating in all 3 parts, and up to 9 months for the subjects participating in Part 3 only.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CSL689 low-dose | Experimental | Drug: CSL689* Part 1: single injection of low-dose CSL689 for PK evaluation * Part 2: up to 2 injections of low-dose CSL689 per bleeding event (bleeding events 1 to 3*) * Part 3: up to 3 injections of low-dose CSL689 per bleeding event * Note: All subjects in the low-dose arm will be treated with high-dose CSL689 for bleeding events 4-6 in Part 2 |
| CSL689 high-dose | Experimental | Drug: CSL689* Part 1: single injection of high-dose CSL689 for PK evaluation * Part 2: up to 2 injections of high-dose CSL689 per bleeding event (bleeding events 4 to 6*) * Part 3: up to 3 injections of high-dose CSL689 per bleeding event * Note: All subjects in the high-dose arm will be treated with low-dose CSL689 for bleeding events 1-3 in Part 2 |
| Eptacog alfa low-dose | Active comparator | Drug: Eptacog alfa (activated)Single injection of low-dose Eptacog alfa in Part 1 for PK evaluation |
| Eptacog alfa high-dose | Active comparator | Drug: Eptacog alfa (activated)Single injection of high-dose Eptacog alfa in Part 1 for PK evaluation |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male subjects with hemophilia A or B and inhibitors.
- Age ≥ 12 and ≤ 65 years.
- High responding inhibitor with documented historical inhibitor titer > 5 Bethesda Units/mL.
Key exclusion criteria (9 listed)
- Congenital or acquired coagulation disorders other than hemophilia A or B.
- Ongoing immune tolerance induction therapy or planned during study.
- Known or suspected hypersensitivity to activated recombinant human FVII or to any excipient of CSL689.
- Body mass index > 30 kg/m².
- Major surgery within 28 days before screening or scheduled major and / or orthopedic surgery during the study.
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 |
|---|---|---|
| CSL689Recombinant fusion protein, linking activated coagulation factor VII with albumin. Two dose levels (low dose, high dose) will be studied in Parts 1, 2, and 3. | Drug | CSL689 high-dose, CSL689 low-dose |
| Eptacog alfa (activated)Recombinant activated coagulation factor VII. Two dose levels (low dose, high dose) will be studied in Part 1. | Drug | Eptacog alfa high-dose, Eptacog alfa low-dose |
Primary outcome
Area under the curve (AUC0-t)
Time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Area under plasma factor VIIa activity versus time curve from time 0 to last sample with quantifiable activity (in Part 1 only).
Incremental recovery
Time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Incremental recovery of plasma factor VIIa activity (in Part 1 only)
Elimination half-life
Time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Elimination half-life of plasma factor VIIa activity (in Part 1 only)
Total clearance
Time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Total clearance of plasma factor VIIa activity (in Part 1 only)
Treatment success with first CSL689 injection
Time frame: Up to 8 hours after first CSL689 injection for each bleeding event
Percentage of bleeding events successfully treated with the first injection of CSL689 for each bleeding event in Part 2.
Treatment success with first CSL689 injection at the population best dose
Time frame: Up to 8 hours after first CSL689 injection for each bleeding event
Percentage of bleeding events successfully treated with the first injection of the population best dose of CSL689 in subjects participating only in Part 3, along with its 95% confidence interval
Treatment success with first or second CSL689 injection at the population best dose
Time frame: Up to 16 hours after first CSL689 injection for each bleeding event
Percentage of bleeding events successfully treated with the first or second injection of the population best dose of CSL689 in subjects participating in Part 3 only, along with its 95% confidence interval
22 secondary outcomes
Treatment success with first or second CSL689 injection
Time frame: Up to 16 hours after first CSL689 injection for each bleeding event
Number of bleeding events requiring > 1 CSL689 injection
Time frame: Up to 8 hours after first CSL689 injection for each bleeding event
Number of CSL689 injections per bleeding event
Time frame: Up to 16 hours (Part 2) or up to 24 hours (Part 3) after first CSL689 injection for each bleeding event
Total dose of CSL689 per bleeding event
Time frame: Up to 16 hours (Part 2) or up to 24 hours (Part 3) after first CSL689 injection for each bleeding event
Treatment success with first CSL689 injection at the population best dose
Time frame: Up to 8 hours after first CSL689 injection for each bleeding event
Percentage of first bleeding events successfully treated with first CSL689 injection at population best dose in Part 3
Time frame: Up to 8 hours after first CSL689 injection for first bleeding event
Treatment success at population best dose
Time frame: Up to 24 hours after first CSL689 injection for each bleeding event
Treatment success with CSL689 at the dose level that is not the population best dose
Time frame: Up to 24 hours after first CSL689 injection for each bleeding event
Percentage of bleeding events with only "definite" or "abrupt" subject-reported pain relief at the population best dose
Time frame: Up to 24 hours after CSL689 injection for each bleeding event
Percentage of bleeding events with "good" or "excellent" investigator-reported assessment of treatment response at the population best dose of CSL689
Time frame: Up to 9 months
Proportion of recurrences
Time frame: Up to 9 months
Proportion of bleeding events with ultrarapid progression.
Time frame: Up to 9 months
Proportion of bleeding events requiring post-hemostatic maintenance dosing
Time frame: Up to 9 months
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: Up to 16 months
Percentage of subjects with TEAEs
Time frame: Up to 16 months
Number of subjects with an antibody response
Time frame: Up to 16 months
Percentage of subjects with an antibody response
Time frame: Up to 16 months
AUC(0-inf)
Time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Maximum observed plasma FVIIa activity (Cmax)
Time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Time of occurrence of maximum observed plasma FVIIa activity (Tmax)
Time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Volume of distribution at steady state (Vss)
Time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Mean residence time (MRT)
Time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689
Results and safety
The study was stopped early (reason given: Business decision non-safety related.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
Study Physician study director
CSL Behring
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CSL689 and Eptacog alfa (activated) in people with Hemophilia A With Inhibitors and Hemophilia B With Inhibitors, run by CSL Behring at 10 sites in 9 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 9 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: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Thailand, Georgia, Italy, Malaysia, Russia and 4 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Business decision non-safety related.). Results are not available in the source record.
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?
Area under the curve (AUC0-t) (time frame: Before injection and at up to 6 time points until 24 hours after injection for Eptacog alfa; before injection and at up to 11 time points until up to 120 hours after injection for CSL689). The study lists 7 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 28 Aug 2019.