Trial · NCT02408484
Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency
NCT02408484, Phase 3, Completed, Octapharma; results first posted 2020-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency. Trials, record NCT02408484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02408484
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency
- NCT number
- NCT02408484
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 15 participants, actual
- Lead sponsor
- Octapharma
- Conditions
- Congenital Fibrinogen Deficiency
- Interventions
- Octafibrin
- First posted
- 2015-04-03
- Last updated
- 2021-01-15
- Results first posted
- 2020-06-11
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | First Octafibrin infusion for the treatment of a bleeding episode until 24 hours (i.e., 1 day) after the last infusion or the end of the treatment observation period, whichever comes last | The overall clinical assessment of the haemostatic efficacy of Octafibrin in treating the first documented bleeding episode (BE) of each patient. The first bleeding episode covered the time from the first Octafibrin infusion until 24 hours (i.e. 1 day) after the last infusion or the end of the treatment observation period, which ever came last. The investigator's overall clinical assessment of haemostatic efficacy for bleeding was based on a 4-point haemostatic efficacy scale (excellent, good, moderate or none). Excellent result was defined as immediate cessation of bleeding; 'Good' was eventual complete cessation of bleeding; 'Moderate' was incomplete cessation of bleeding and 'None' was no cessation of bleeding with alternative haemostatic intervention required. The IDMEAC conducted an independent adjudication of all haemostatic efficacy results and evaluated the investigator's assessments of the efficacy in the treatment of each BE. |
| Primary | Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 2-point Haemostatic Efficacy Scale | From the first Octafibrin infusion until 24 hours (i.e. 1 day) after the last infusion or the end of the treatment observation period, which ever came last. | The overall clinical assessment of the haemostatic efficacy of Octafibrin in treating the first documented bleeding episode (BE) of each patient. The first bleeding episode covered the time from the first Octafibrin infusion until 24 hours (i.e. 1 day) after the last infusion or the end of the treatment observation period, which ever came last. The investigator's overall clinical assessment of haemostatic efficacy for bleeding was based on a 2-point haemostatic efficacy scale (success and failure). Efficacy rating of excellent or good on the four-point scale (above) indicated success and efficacy rating of moderate or none indicated failure. The IDMEAC conducted an independent adjudication of all haemostatic efficacy results and evaluated the investigator's assessments of the efficacy in the treatment of each BE. |
| Secondary | Single-dose Pharmacokinetics of Octafibrin: Area Under the Concentration-time Curve Normalised (AUCnorm) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | AUCnorm (Area under the concentration-time curve normalized to the dose administered) was assessed after a single intravenous infusion of 70 mg/kg body weight of Octafibrin. |
| Secondary | Single-dose Pharmacokinetics of Octafibrin: Response - Incremental in Vivo Recovery (IVR) | Between the pre-infusion and the 3-hour post-infusion | IVR was assessed after a single intravenous infusion of 70 mg/kg body weight of Octafibrin. |
| Secondary | Single-dose Pharmacokinetics of Octafibrin: Terminal Elimination Half-life (t1/2) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | t1/2 was assessed after a single intravenous infusion of 70 mg/kg body weight of Octafibrin. |
| Secondary | Single-dose Pharmacokinetics of Octafibrin: Maximum Plasma Concentration (Cmax) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | Cmax was assessed after a single intravenous infusion of 70 mg/kg body weight of Octafibrin. |
| Secondary | Single-dose Pharmacokinetics of Octafibrin: Time to Reach Maximum Plasma Concentration (Tmax) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | Tmax was assessed after a single intravenous infusion of 70 mg/kg body weight of Octafibrin. |
| Secondary | Single-dose Pharmacokinetics of Octafibrin: Mean Residence Time (MRT) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | MRT was assessed after a single intravenous infusion of 70 mg/kg body weight of Octafibrin. |
| Secondary | Single-dose Pharmacokinetics of Octafibrin: Volume of Distribution (Vss) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | Vss was assessed after a single intravenous infusion of 70 mg/kg body weight of Octafibrin. |
| Secondary | Single-dose Pharmacokinetics of Octafibrin: Clearance (Cl) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | Cl was assessed after a single intravenous infusion of 70 mg/kg body weight of Octafibrin. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | First Octafibrin infusion for the treatment of a bleeding episode until 24 hours (i.e., 1 day) after the last infusion or the end of the treatment observation period, whichever comes last | The analysis was performed in the firstBLEED population which included patients in the full-analysis (FAS) population who had at least one bleeding episode treated with Octafibrin (n=8). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 2-point Haemostatic Efficacy Scale | From the first Octafibrin infusion until 24 hours (i.e. 1 day) after the last infusion or the end of the treatment observation period, which ever came last. | The analysis was performed in the firstBLEED population which included patients in the full-analysis (FAS) population who had at least one bleeding episode treated with Octafibrin (n=8). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Single-dose Pharmacokinetics of Octafibrin: Area Under the Concentration-time Curve Normalised (AUCnorm) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | The analysis was performed in the pharmacokinetic (PK) population which included all patients in the full-analysis (FAS) population who underwent PK assessment and had at least one valid post-baseline fibrinogen activity level (n=13). | h*kg*g/L/mg | MEAN |
| SECONDARY | Single-dose Pharmacokinetics of Octafibrin: Response - Incremental in Vivo Recovery (IVR) | Between the pre-infusion and the 3-hour post-infusion | The analysis was performed in the pharmacokinetic (PK) population which included all patients in the full-analysis (FAS) population who underwent PK assessment and had at least one valid post-baseline fibrinogen activity level (n=13) | mg/dL/(mg/kg) | MEAN |
| SECONDARY | Single-dose Pharmacokinetics of Octafibrin: Terminal Elimination Half-life (t1/2) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | The analysis was performed in the pharmacokinetic (PK) population, which included all patients in the full-analysis (FAS) population who underwent PK assessment and had at least one valid post-baseline fibrinogen activity level (n=13). | hours | MEAN |
| SECONDARY | Single-dose Pharmacokinetics of Octafibrin: Maximum Plasma Concentration (Cmax) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | The analysis was performed in the pharmacokinetic (PK) population, which included all patients in the full-analysis (FAS) population who underwent PK assessment and had at least one valid post-baseline fibrinogen activity level. | g/L | MEAN |
| SECONDARY | Single-dose Pharmacokinetics of Octafibrin: Time to Reach Maximum Plasma Concentration (Tmax) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | The analysis was performed in the pharmacokinetic (PK) population, which included all patients in the full-analysis (FAS) population who underwent PK assessment and had at least one valid post-baseline fibrinogen activity level (n=13). | hours | MEAN |
| SECONDARY | Single-dose Pharmacokinetics of Octafibrin: Mean Residence Time (MRT) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | The analysis was performed in the pharmacokinetic (PK) population, which included all patients in the full-analysis (FAS) population who underwent PK assessment and had at least one valid post-baseline fibrinogen activity level (n=13). | hours | MEAN |
| SECONDARY | Single-dose Pharmacokinetics of Octafibrin: Volume of Distribution (Vss) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | The analysis was performed in the pharmacokinetic (PK) population, which included all patients in the full-analysis (FAS) population who underwent PK assessment and had at least one valid post-baseline fibrinogen activity level. | mL/kg | MEAN |
| SECONDARY | Single-dose Pharmacokinetics of Octafibrin: Clearance (Cl) | Before first infusion, 1 hour, 3 hours, 1 day, 2 days, 4 days, 7 days, 10 days and 14 days post-infusion | The analysis was performed in the pharmacokinetic (PK) population, which included all patients in the full-analysis (FAS) population who underwent PK assessment and had at least one valid post-baseline fibrinogen activity level. | mL/h/kg | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | Investigator Assessment | Excellent | 5 | Participants | |
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | IDMEAC Assessment | Excellent | 6 | Participants | |
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | Investigator Assessment | Good | 1 | Participants | |
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | IDMEAC Assessment | Good | 2 | Participants | |
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | Investigator Assessment | Moderate | 1 | Participants | |
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | IDMEAC Assessment | Moderate | 0 | Participants | |
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | Investigator Assessment | None | 1 | Participants | |
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 4-point Haemostatic Efficacy Scale | IDMEAC Assessment | None | 0 | Participants | |
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 2-point Haemostatic Efficacy Scale | Investigator Assessment | Success | 6 | Participants | |
| Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a 2-point Haemostatic Efficacy Scale | IDMEAC Assessment | Success | 8 | Participants |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Octafibrin | 15 | |
| Overall Study | SAF Population | Octafibrin | 14 | |
| Overall Study | FAS Population | Octafibrin | 14 | |
| Overall Study | PK Population | Octafibrin | 13 | |
| Overall Study | firstBLEED Population | Octafibrin | 8 | |
| Overall Study | BLEED Population | Octafibrin | 8 | |
| Overall Study | SURG Population | Octafibrin | 3 | |
| Overall Study | COMPLETED | Octafibrin | 11 | |
| Overall Study | NOT COMPLETED | Octafibrin | 4 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ecchymosis | Skin and subcutaneous tissue disorders | Octafibrin | 2 | 14 | 3 |
| other | Influenza-like illness | General disorders | Octafibrin | 1 | 14 | 1 |
| other | Pyrexia | General disorders | Octafibrin | 1 | 14 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Octafibrin | 1 | 14 | 1 |
| other | Tonsillitis | Infections and infestations | Octafibrin | 1 | 14 | 1 |
| other | Procedural pain | Injury, poisoning and procedural complications | Octafibrin | 1 | 14 | 1 |
| other | Haemarthrosis | Musculoskeletal and connective tissue disorders | Octafibrin | 1 | 14 | 1 |
| serious | Portal Vein Thrombosis | Hepatobiliary disorders | Octafibrin | 1 | 14 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octafibrin | 0 | 14 |
| Total, other adverse events | Octafibrin | 4 | 14 |
| Total, serious adverse events | Octafibrin | 1 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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