Trial · NCT01575756
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
NCT01575756, Phase 2, Completed, Octapharma; results first posted 2016-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap. Trials, record NCT01575756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01575756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
- NCT number
- NCT01575756
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Octapharma
- Conditions
- Congenital Fibrinogen Deficiency, Afibrinogenemia
- Interventions
- Octafibrin, Haemocomplettan® P or RiaSTAPTM
- First posted
- 2012-04-11
- Last updated
- 2018-03-09
- Results first posted
- 2016-11-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The mean ratio of normalized area under the curve was calculated as Octafibrin/FIBRYGA® over Haemocomplettan® P/RiaSTAP(TM) |
| Primary | Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion | 1 hour post-treatment | Thromboelastometry (ROTEM®) was used to measure maximum clot firmness. Thromboelastometry is a method for the continuous measurement of clot formation. Maximum clot firmness is a functional parameter that depends on the activation of coagulation, the platelet and fibrinogen content of the blood sample, and the polymerisation and cross-linking of the fibrin network. In order to obtain comparable results from all study centres, maximum clot firmness data were assessed from frozen citrated plasma samples in a central laboratory. As these samples did not contain platelets that would be found in the whole blood assay, the fibrinogen content primarily defined the maximum clot firmness. |
| Secondary | Fibrinogen Activity Normalized Area Under the Curve Unstandardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. |
| Secondary | Fibrinogen Activity Normalized Area Under the Curve Standardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The normalized area under the curve was standardized to a dose of 70 mg/kg. |
| Secondary | Maximum Plasma Concentration Normalized (Cmaxnorm) | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. |
| Secondary | Maximum Plasma Concentration (Cmax) Unstandardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. |
| Secondary | Maximum Plasma Concentration (Cmax) Standardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The maximum plasma concentration was standardized to a dose of 70 mg/kg. |
| Secondary | Incremental in Vivo Recovery | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Incremental in vivo recovery was calculated as the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg/kg dosed). |
| Secondary | Classical in Vivo Recovery | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Classical in vivo recovery was calculated as: 100 x the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma) x the plasma volume (mL), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg). |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | ratio | MEAN |
| PRIMARY | Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion | 1 hour post-treatment | Full analysis set: All randomised participants who received at least 1 infusion of study medication (Octafibrin/FIBRYGA®) and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)) and for whom any post-treatment data were available. | mm | MEAN |
| SECONDARY | Fibrinogen Activity Normalized Area Under the Curve Unstandardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | h•kg•g/L/mg | MEAN |
| SECONDARY | Fibrinogen Activity Normalized Area Under the Curve Standardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | g•h/L | MEAN |
| SECONDARY | Maximum Plasma Concentration Normalized (Cmaxnorm) | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | kg•g/L/mg | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) Unstandardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | g/L | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) Standardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | g•h/L | MEAN |
| SECONDARY | Incremental in Vivo Recovery | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | mg/dL/(mg/kg) | MEAN |
| SECONDARY | Classical in Vivo Recovery | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | percentage | MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | h | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized | Pharmacokinetic (PK)-Per Protocol Dataset | 1.196 | 90% Confidence Interval 1.117 to 1.281 | ratio | |
| Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion | Octafibrin/FIBRYGA® | 9.68 | 95% Confidence Interval 8.37 to 10.99 | mm | |
| Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion | Haemocomplettan® P/RiaSTAP(TM) | 10.00 | 95% Confidence Interval 8.07 to 11.93 | mm | |
| Fibrinogen Activity Normalized Area Under the Curve Unstandardized | Octafibrin/FIBRYGA® | 1.62 | Standard Deviation 0.45 | h•kg•g/L/mg | |
| Fibrinogen Activity Normalized Area Under the Curve Unstandardized | Haemocomplettan® P/RiaSTAP(TM) | 1.38 | Standard Deviation 0.47 | h•kg•g/L/mg | |
| Fibrinogen Activity Normalized Area Under the Curve Standardized | Octafibrin/FIBRYGA® | 113.70 | Standard Deviation 31.54 | g•h/L | |
| Fibrinogen Activity Normalized Area Under the Curve Standardized | Haemocomplettan® P/RiaSTAP(TM) | 96.39 | Standard Deviation 32.89 | g•h/L | |
| Maximum Plasma Concentration Normalized (Cmaxnorm) | Octafibrin/FIBRYGA® | 0.018 | Standard Deviation 0.005 | kg•g/L/mg | |
| Maximum Plasma Concentration Normalized (Cmaxnorm) | Haemocomplettan® P/RiaSTAP(TM) | 0.018 | Standard Deviation 0.005 | kg•g/L/mg | |
| Maximum Plasma Concentration (Cmax) Unstandardized | Octafibrin/FIBRYGA® | 1.390 | Standard Deviation 0.369 | g/L |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM) | 11 | |
| Treatment Period 1 | STARTED | Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA® | 11 | |
| Treatment Period 1 | COMPLETED | Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM) | 11 | |
| Treatment Period 1 | COMPLETED | Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA® | 11 | |
| Treatment Period 1 | NOT COMPLETED | Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM) | 0 | |
| Treatment Period 1 | NOT COMPLETED | Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA® | 0 | |
| Treatment Period 2 | STARTED | Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM) | 11 | |
| Treatment Period 2 | STARTED | Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA® | 11 | |
| Treatment Period 2 | COMPLETED | Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM) | 11 | |
| Treatment Period 2 | COMPLETED | Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA® | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events78
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 | Vertigo | Ear and labyrinth disorders | Octafibrin/FIBRYGA® | 0 | 22 | |
| other | Vertigo | Ear and labyrinth disorders | Haemocomplettan® P/RiaSTAP(TM) | 1 | 22 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Octafibrin/FIBRYGA® | 0 | 22 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Haemocomplettan® P/RiaSTAP(TM) | 1 | 22 | |
| other | Diarrhoea | Gastrointestinal disorders | Octafibrin/FIBRYGA® | 1 | 22 | |
| other | Diarrhoea | Gastrointestinal disorders | Haemocomplettan® P/RiaSTAP(TM) | 1 | 22 | |
| other | Dyspepsia | Gastrointestinal disorders | Octafibrin/FIBRYGA® | 1 | 22 | |
| other | Dyspepsia | Gastrointestinal disorders | Haemocomplettan® P/RiaSTAP(TM) | 0 | 22 | |
| other | Food poisoning | Gastrointestinal disorders | Octafibrin/FIBRYGA® | 0 | 22 | |
| other | Food poisoning | Gastrointestinal disorders | Haemocomplettan® P/RiaSTAP(TM) | 1 | 22 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octafibrin/FIBRYGA® | 0 | 22 |
| Total, all-cause mortality | Haemocomplettan® P/RiaSTAP(TM) | 0 | 22 |
| Total, other adverse events | Octafibrin/FIBRYGA® | 11 | 22 |
| Total, other adverse events | Haemocomplettan® P/RiaSTAP(TM) | 11 | 22 |
| Total, serious adverse events | Octafibrin/FIBRYGA® | 1 | 22 |
| Total, serious adverse events | Haemocomplettan® P/RiaSTAP(TM) | 0 | 22 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Octafibrin/FIBRYGA® vs Haemocomplettan® P/RiaSTAP(TM): deaths from any cause | Trial comparisons |
| Octafibrin/FIBRYGA® vs Haemocomplettan® P/RiaSTAP(TM): serious adverse events | Trial comparisons |
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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Read this trial from software.
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