Hemophilia APhase 4NCT00916032

Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A

A Phase 4 study testing Octocog alfa (recombinant human coagulation factor VIII) [ADVATE] in people with Hemophilia A, run by Baxalta now part of Shire at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate using two vials of 1500 IU potency dissolved in 5 mL diluent each (administered in 10 mL diluent in total) in previously treated… Read more about this study

Who is it for?: Ages 18 to 65 years, men only
Conditions the study is for: Hemophilia A
What is being tested?: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 4 sitesin 2 countries
Study dates: 29 Jun 2009to 1 Apr 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant is 18 to 65 years old, at the time of screening
Participant has provided signed informed consent
Participant has severe hemophilia A, defined by a baseline FVIII level < 1% of normal, as tested at screening at the central laboratory
Participant's weight is between 55-65 kg
Participant was previously treated with FVIII concentrate(s) for a minimum of 150 exposure days prior to study entry
If Participant is HIV positive, he must be immunocompetent as determined with a CD4 count ≥ 200 cells/mm³ (CD4 count at screening)
Participant is willing and able to comply with the requirements of the protocol

Who cannot join

Participant has a detectable FVIII inhibitor at screening, with a titer ≥ 0.4 Bethesda unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the central laboratory
Participant has a history of FVIII inhibitors with a titer ≥ 0.4 BU (by Nijmegen assay) or ≥ 0.5 BU (by Bethesda Assay) at any time prior to screening
Participant has undergone a surgery within 21 days prior to screening or within 6 weeks prior to the anticipated first pharmacokinetics(PK) infusion
Participant has an abnormal renal function (serum creatinine > 1.5 mg/dL)
Participant has active hepatic disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >5 times the upper limit of normal)
Participant has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly, and history of esophageal varices

Show all 12Show fewer

Participant has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (eg, late-stage chronic liver disease, immune thrombocytopenia purpura)
Participant is currently receiving, or is scheduled to receive during the course of the clinical study, an immunomodulating drug other than anti-retroviral chemotherapy (eg, alfa-interferon, or corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day)
Participant has a known hypersensitivity to mouse or hamster proteins
Participant has participated in another clinical study involving an investigational product or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this clinical study
Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures
Participant is a member of the team conducting this clinical study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, or parents) as well as employees of the investigator or site personnel conducting the clinical study.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Russia3 sites

Study site
Kirov
Study site
Moscow, 125167
Study site
Saint Petersburg, 195213

Other trials in Russia

Bulgaria1 site

Study site
Sofia, 1233

Other trials in Bulgaria

About this study

Official title: Pharmacokinetic Comparison of 3000 IU Advate (rAHF-PFM) (Using One 3000 IU Potency Vial) With 3000 IU Advate (rAHF PFM) (Using Two 1500 IU Potency Vials) in Previously Treated Patients With Severe Hemophilia A: a Phase 4, Open-label, Prospective, Randomized, Controlled, Crossover, Multiple Center Study

Conditions: Hemophilia A
Being tested: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
Medical subject headings: Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]Biological
Also called ADVATE, Antihemophilic Factor (Recombinant)- Plasma/albumin free method (rAHF-PFM)
Participants will receive 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence

Study groups in NCT00916032
Study group	Role	What they receive
1	Active comparator	One infusion using a 3000 IU potency vial of Advate dissolved and administered in 5 mL diluent followed by a second infusion of two 1500 IU potency vials of Advate dissolved in 5 mL diluent each (administered in 10 mL diluent in total) Receives: Biological: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
2	Active comparator	One infusion of two 1500 IU potency vials of Advate dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by a second infusion of one 3000 IU potency vial of Advate dissolved and administered in 5 mL diluent Receives: Biological: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay
Computed using the linear trapezoidal method.
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay
Computed using the linear trapezoidal method.
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.

Secondary outcomes (16)

Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay
The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay
The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Incremental Recovery at Cmax - Chromogenic Assay
Determined as the highest Factor VIII (FVIII) activity achieved post-infusion
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.
Incremental Recovery at Cmax - One-stage aPTT Assay
Determined as the highest FVIII activity achieved post-infusion
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.
Incremental Recovery at 30 Minutes- Chromogenic Assay
Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion
Measured: 30 minutes pre-infusion and 30 minutes post-infusion
Incremental Recovery at 30 Minutes- One-stage aPTT Assay
Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion
Measured: 30 minutes pre-infusion and 30 minutes post-infusion
Elimination Phase Half-life- Chromogenic Assay
calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Elimination Phase Half-life- One-stage aPTT Assay
calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
FVIII Clearance- Chromogenic Assay
computed as the dose divided by total AUC
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
FVIII Clearance- One-stage aPTT Assay
Computed as the dose divided by total AUC
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Mean Residence Time (MRT)- Chromogenic Assay
Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Mean Residence Time (MRT)- One-stage aPTT Assay
Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Volume of Distribution at Steady State- Chromogenic Assay
computed as Clearance (CL) * Mean residence time (MRT)
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Volume of Distribution at Steady State- One-stage aPTT Assay
computed as CL * MRT
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay
Determined as the highest FVIII activity achieved post-infusion.
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay
Determined as the highest FVIII activity achieved post-infusion.
Measured: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 20091 Apr 2010

First posted8 Jun 2009 (estimated)
Study start29 Jun 2009
Primary completion1 Apr 2010
Study completion1 Apr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hemophilia AStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00916032
Sponsor's protocol ID: 060801
Other IDs: 2008-007347-13, 2008
Status last verified: Apr 2021
First submitted: 5 Jun 2009
Last updated: 19 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hemophilia A trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Comparison of 3000 IU Advate (rAHF-PFM) (Using One 3000 IU Potency Vial) With 3000 IU Advate (rAHF PFM) (Using Two 1500 IU Potency Vials) in Previously Treated Patients With Severe Hemophilia A: a Phase 4, Open-label, Prospective, Randomized, Controlled, Crossover, Multiple Center Study
ClinicalTrials.gov ID: NCT00916032
Acronym / sponsor ID: 060801
Conditions: Hemophilia A
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Baxalta now part of ShireIndustry (pharma, biotech, devices)
Study start: 29 Jun 2009 (actual)
Primary completion: 1 Apr 2010 (actual)
Study completion: 1 Apr 2010 (actual)
First posted: 8 Jun 2009 (estimated)
Results: Posted 5 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Biological: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]One infusion using a 3000 IU potency vial of Advate dissolved and administered in 5 mL diluent followed by a second infusion of two 1500 IU potency vials of Advate dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
2	Active comparator	Biological: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]One infusion of two 1500 IU potency vials of Advate dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by a second infusion of one 3000 IU potency vial of Advate dissolved and administered in 5 mL diluent

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participant is 18 to 65 years old, at the time of screening
Participant has provided signed informed consent
Participant has severe hemophilia A, defined by a baseline FVIII level < 1% of normal, as tested at screening at the central laboratory
Participant's weight is between 55-65 kg
Participant was previously treated with FVIII concentrate(s) for a minimum of 150 exposure days prior to study entry

Key exclusion criteria (12 listed)

Participant has a detectable FVIII inhibitor at screening, with a titer ≥ 0.4 Bethesda unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the central laboratory
Participant has a history of FVIII inhibitors with a titer ≥ 0.4 BU (by Nijmegen assay) or ≥ 0.5 BU (by Bethesda Assay) at any time prior to screening
Participant has undergone a surgery within 21 days prior to screening or within 6 weeks prior to the anticipated first pharmacokinetics(PK) infusion
Participant has an abnormal renal function (serum creatinine > 1.5 mg/dL)
Participant has active hepatic disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >5 times the upper limit of normal)

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
Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]Also: ADVATE, Antihemophilic Factor (Recombinant)- Plasma/albumin free method (rAHF-PFM)Participants will receive 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence	Biological	1, 2

Primary outcome

Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Computed using the linear trapezoidal method.
Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Computed using the linear trapezoidal method.

16 secondary outcomes

Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Incremental Recovery at Cmax - Chromogenic Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.
Incremental Recovery at Cmax - One-stage aPTT Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.
Incremental Recovery at 30 Minutes- Chromogenic Assay
Time frame: 30 minutes pre-infusion and 30 minutes post-infusion
Incremental Recovery at 30 Minutes- One-stage aPTT Assay
Time frame: 30 minutes pre-infusion and 30 minutes post-infusion
Elimination Phase Half-life- Chromogenic Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Elimination Phase Half-life- One-stage aPTT Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
FVIII Clearance- Chromogenic Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
FVIII Clearance- One-stage aPTT Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Mean Residence Time (MRT)- Chromogenic Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Mean Residence Time (MRT)- One-stage aPTT Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Volume of Distribution at Steady State- Chromogenic Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Volume of Distribution at Steady State- One-stage aPTT Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.
Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay
Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.

Results and safety

Results posted to the registry on 5 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Two 1500 IU Vials Then One 3000 IU Vial	12	12
One 3000 IU Vial Then Two 1500 IU Vials	11	11

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay

Time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.. Mean (Standard Deviation). Unit: (IU·h)/dL

Measure	One 3000 International Unit (IU) Vial n = 23	Two 1500 IU Vials n = 23
Value	1158 (335)	1264 (364)

One 3000 International Unit (IU) Vial vs Two 1500 IU Vials: p = 0.103, paired t-test done on the Log(AUC 0-48h)

Population analysed: Intent to Treat

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay

Measure	One 3000 International Unit (IU) Vial n = 23	Two 1500 IU Vials n = 23
Value	1129 (310)	1226 (358)

One 3000 International Unit (IU) Vial vs Two 1500 IU Vials: p = 0.162, paired t-test done on the Log(AUC 0-48h)

Population analysed: Intent to Treat

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period, approximately 10 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
One 3000 International Unit (IU) Vial	0 of 23 (0%)	0 of 23 (0%)	Not reported
Two 1500 IU Vials	0 of 23 (0%)	0 of 23 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hemophilia A

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
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RecruitingPhase 1/2
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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 Director study director

Takeda

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Octocog alfa (recombinant human coagulation factor VIII) [ADVATE] in people with Hemophilia A, run by Baxalta now part of Shire at 4 sites in 2 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 7 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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Russia, Bulgaria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay (time frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.). 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?

On the ClinicalTrials.gov record for NCT00916032.

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 19 May 2021.