Fibrinogen DeficiencyPhase 2NCT00496262

Human Fibrinogen - Pharmacokinetics

A Phase 2 study testing Human Fibrinogen Concentrate in people with Fibrinogen Deficiency, run by CSL Behring at 15 sites in 2 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 6 years and older
Conditions the study is for: Fibrinogen Deficiency
What is being tested?: Human Fibrinogen Concentrate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 15 sitesin 2 countries
Study dates: Jul 2007to May 2008
Phase: Phase 2
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 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Aged ≥ 6 years
Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as afibrinogenemia with plasma fibrinogen activity and antigen at screening undetectable (i.e. < 20 mg/dL)
Informed consent signed by subject or legal guardian

Who cannot join

Presence or history of hypersensitivity to Human Fibrinogen Concentrate or human plasma proteins,
Presence or history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis
Acute bleeding
History of esophageal varicose bleeding
End stage liver disease (i.e. Child-Pugh score B or C)
Planned major surgery with a need for blood transfusion during the PK blood sampling period
Polytrauma within 1 year prior to enrollment

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

Italy9 sites

Contact CSL Behring for facility details
Cagliari, 09100
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Florence, 50134
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Milan, 20122
Contact CSL Behring for facility details
Naples, 80122
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Padova, 35128
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Palermo, 90134
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Rome, 00161
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Sassari, 07100
Contact CSL Behring for facility details
Vicenza, 36100

Other trials in Italy

United States6 sites

Contact CSL Behring for facility details
Aurora, Colorado, 80045
Contact CSL Behring for facility details
Chicago, Illinois, 60614
Contact CSL Behring for facility details
New York, New York, 10021
Contact CSL Behring for facility details
Pittsburgh, Pennsylvania, 15232
Contact CSL Behring for facility details
Scarborough, Maine, 04074-9308
Contact CSL Behring for facility details
St. Petersburg, Florida, 33701

Other trials in United States

About this study

Official title: Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.

Conditions: Fibrinogen Deficiency
Being tested: Human Fibrinogen Concentrate
Keywords: Congenital fibrinogen deficiency, Fibrinogen concentrate, Pharmacokinetics, Thrombelastography
Medical subject headings: Afibrinogenemia

What participants receive

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

Human Fibrinogen ConcentrateBiological
Also called Haemocomplettan® P, RiaSTAP
Single intravenous infusion of 70 mg/kg body weight

Study groups in NCT00496262
Study group	Role	What they receive
Human Fibrinogen Concentrate	Experimental	Not described Receives: Biological: Human Fibrinogen Concentrate

What is being measured

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

Maximum Clot Firmness (MCF)
MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.
Measured: Pre-infusion and 1 hour post-infusion

Secondary outcomes (8)

Terminal Elimination Half-life (t1/2)
t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Measured: 0.5 hours to 13 days post-infusion
Maximum Concentration (Cmax)
Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Measured: Pre-infusion to 13 days post-infusion
Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose
AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Measured: Pre-infusion to 13 days post-infusion
Clearance (Cl)
Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Measured: Pre-infusion to 13 days post-infusion
Mean Residence Time (MRT)
MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Measured: Pre-infusion to 13 days post-infusion
Volume of Distribution at Steady State (Vss)
Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.
Measured: Pre-infusion to 13 days post-infusion
Incremental In Vivo Recovery (IVR)
Maximum fibrinogen activity increase in plasma per mg/kg dosed
Measured: Pre-infusion to 4 hours post-infusion
Classical In Vivo Recovery (IVR)
Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose
Measured: Pre-infusion to 4 hours post-infusion

Timeline

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

Jul 2007May 2008

First posted4 Jul 2007 (estimated)
Study startJul 2007
Primary completionMay 2008
Study completionMay 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Fibrinogen DeficiencyStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00496262
Sponsor's protocol ID: BI3023_2001
Status last verified: Feb 2011
First submitted: 3 Jul 2007
Last updated: 15 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Manco-Johnson MJ, Dimichele D, Castaman G, Fremann S, Knaub S, Kalina U, Peyvandi F, Piseddu G, Mannucci P; FIBRINOGEN CONCENTRATE STUDY GROUP. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost. 2009 Dec;7(12):2064-9. doi: 10.1111/j.1538-7836.2009.03633.x. Epub 2009 Oct 5.
PubMed 19804533

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

Enrolling by invitationObservational study
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
Hypofibrinogenemia, Hemorrhage
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Acquired Fibrinogen Deficiency
RecruitingObservational study
Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
Trauma Induced Coagulopathy, Trauma Coagulopathy
Not yet recruitingObservational study
Individualized Dose of Fibrinogen Following Cardiopulmonary Bypass
Fibrinogen Deficiency in Complex Cardiac Surgery
RecruitingObservational study
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
IGF1 Deficiency

All Fibrinogen Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency
ClinicalTrials.gov ID: NCT00496262
Acronym / sponsor ID: BI3023_2001
Conditions: Fibrinogen Deficiency
Keywords: Congenital fibrinogen deficiency, Fibrinogen concentrate, Pharmacokinetics, Thrombelastography
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: CSL BehringIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 4 Jul 2007 (estimated)
Results: Posted 10 Jul 2009

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Human Fibrinogen Concentrate	Experimental	Biological: Human Fibrinogen Concentrate

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Aged ≥ 6 years
Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as afibrinogenemia with plasma fibrinogen activity and antigen at screening undetectable (i.e. < 20 mg/dL)
Informed consent signed by subject or legal guardian

Key exclusion criteria (7 listed)

Presence or history of hypersensitivity to Human Fibrinogen Concentrate or human plasma proteins,
Presence or history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis
Acute bleeding
History of esophageal varicose bleeding
End stage liver disease (i.e. Child-Pugh score B or C)

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
Human Fibrinogen ConcentrateAlso: Haemocomplettan® P, RiaSTAPSingle intravenous infusion of 70 mg/kg body weight	Biological	Human Fibrinogen Concentrate

Primary outcome

Maximum Clot Firmness (MCF)
Time frame: Pre-infusion and 1 hour post-infusion
MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.

8 secondary outcomes

Terminal Elimination Half-life (t1/2)
Time frame: 0.5 hours to 13 days post-infusion
Maximum Concentration (Cmax)
Time frame: Pre-infusion to 13 days post-infusion
Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose
Time frame: Pre-infusion to 13 days post-infusion
Clearance (Cl)
Time frame: Pre-infusion to 13 days post-infusion
Mean Residence Time (MRT)
Time frame: Pre-infusion to 13 days post-infusion
Volume of Distribution at Steady State (Vss)
Time frame: Pre-infusion to 13 days post-infusion
Incremental In Vivo Recovery (IVR)
Time frame: Pre-infusion to 4 hours post-infusion
Classical In Vivo Recovery (IVR)
Time frame: Pre-infusion to 4 hours post-infusion

Results and safety

Results posted to the registry on 10 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Human Fibrinogen Concentrate	15	15

Primary outcome: Maximum Clot Firmness (MCF)

Time frame: Pre-infusion and 1 hour post-infusion. Mean (Standard Deviation). Unit: millimeters

Measure	Pre-infusion n = 15	1 Hour Post-infusion n = 15
Value	0 (0)	8.9 (4.4)

Pre-infusion vs 1 Hour Post-infusion: Mean Difference (Net): 8.9, p <0.0001, 2-sided, 1-sample t-test

Population analysed: All subjects in the intention to treat (ITT) population. The ITT population included all subjects who received any portion of any infusion of human fibrinogen concentrate. (Note: 2 subjects in the ITT population had missing MCF data; the change from baseline MCF was entered as 0.0 for these subjects.)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Human Fibrinogen Concentrate	0 of 15 (0%)	2 of 15 (13.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19804533Manco-Johnson MJ, Dimichele D, Castaman G, Fremann S, Knaub S, Kalina U, Peyvandi F, Piseddu G, Mannucci P; FIBRINOGEN CONCENTRATE STUDY GROUP. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost. 2009 Dec;7(12):2064-9. doi: 10.1111/j.1538-7836.2009.03633.x. Epub 2009 Oct 5.

Related trials for Fibrinogen Deficiency

Enrolling by invitationObservational study
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
Hypofibrinogenemia, Hemorrhage
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Acquired Fibrinogen Deficiency
RecruitingObservational study
Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
Trauma Induced Coagulopathy, Trauma Coagulopathy
Not yet recruitingObservational study
Individualized Dose of Fibrinogen Following Cardiopulmonary Bypass
Fibrinogen Deficiency in Complex Cardiac Surgery
RecruitingObservational study
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
IGF1 Deficiency

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.

Program Director, Clinical R&D study director

CSL Behring

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Human Fibrinogen Concentrate in people with Fibrinogen Deficiency, run by CSL Behring at 15 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 3 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Italy, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 10 Jul 2009). 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?

Maximum Clot Firmness (MCF) (time frame: Pre-infusion and 1 hour post-infusion). 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 NCT00496262, which also lists 1 linked publication.

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 15 Sep 2016.