Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery

NCT05523297

Bleeding Cardiac Surgery Patients

COMPLETED PHASE3

Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients

NCT04376762

Pediatric HD Bleeding

COMPLETED PHASE4

FIBrinogen REplenishment in Surgery

NCT03037424

Deficiency; Fibrinogen, Acquired

COMPLETED PHASE3

Analyzes of Hemorrhagic Obstetric Patients Whose Were Used Fibrinogen

NCT03723200

Hemorrhage

COMPLETED

Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section

NCT04427618

Postpartum Hemorrhage Tranexamic Acid

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Fibrinogen Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Octafibrin

Group Type EXPERIMENTAL

Octafibrin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Octafibrin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged ≥12 years (only 18 and above in Russia)
* Documented diagnosis of congenital fibrinogen deficiency, expected to require on-demand treatment for bleeding or surgical prophylaxis:
* Fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrinogenaemia.
* Historical plasma fibrinogen activity of \<50 mg/dL or levels below the limit of detection of the local assay method.
* Expected to have an acute bleeding episode (spontaneous or after trauma) or planning to undergo elective surgery.
* Informed consent signed by the subject or legal guardian.

Exclusion Criteria

* Life expectancy \<6 months.
* Bleeding disorder other than congenital fibrinogen deficiency, including dysfibrinogenaemia.
* Prophylactic treatment with a fibrinogen concentrate.

Treatment with:

* Any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks prior to start of treatment for the bleeding episode or surgery.
* Any coagulation-active drug (i.e., non-steroidal anti-inflammatory drugs, warfarin, coumarin derivatives, platelet aggregation inhibitors) within 1 week prior to start of treatment for the bleeding episode or surgery, or as a planned or expected medication during the time period from Day 1 until 24 hours (i.e., 1 day) after the last Octafibrin infusion.

Presence or history of:

* Hypersensitivity to study medication.
* Deep vein thrombosis or pulmonary embolism within 1 year prior to start of treatment for the bleeding episode or surgery.
* Arterial thrombosis within 1 year prior to start of treatment for the bleeding episode or surgery
* Hypersensitivity to human plasma proteins.
* Oesophageal varicose bleeding.
* End-stage liver disease (i.e., Child-Pugh score B or C).

Pregnant women within the first 20 weeks of gestation.

Currently breast-feeding.

Known positive HIV infection with a viral load \>200 particles/μL or \>400,000 copies/mL.

Polytrauma 1 year prior to start of treatment for the bleeding episode or surgery.

Diagnosis or suspicion of a neutralizing anti-fibrinogen inhibitor currently or any time in the past.

Acute or chronic medical condition which may, in the opinion of investigator, affect the conduct of the study, including

* Subjects receiving immune-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to \>10 mg/day), or similar drugs at study start.
* Subjects having evidence or a history (within the previous 12 months) of abuse of any licit or illicit drug substance.

Participation in another interventional clinical study currently or during the past 4 weeks.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No