Trial · NCT00708435
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
NCT00708435, Phase 3, Completed, CSL Behring; results first posted 2013-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy. Trials, record NCT00708435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00708435
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
- NCT number
- NCT00708435
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 216 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Blood Coagulation Disorders, Acute Major Bleeding
- Interventions
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- First posted
- 2008-07-02
- Last updated
- 2014-02-03
- Other registries' IDs
- eudract:2007-007861-19
- Results first posted
- 2013-08-13
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed | At 1 and 4 hours after the end of infusion | Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none". |
| Primary | Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR) | 30 minutes after end of infusion | A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy. |
| Secondary | Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding | At 3 and 6 hours after the start of infusion | Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 3 and 6 hours after the start of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none". |
| Secondary | Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex | Before infusion and up to 3 h after the start of infusion | The incremental IVR \[(IU/dL)/(IU/kg)\] was calculated as follows: (IU/dL activity rise in plasma)/(IU/kg body weight infused) = \[maximum increase in component plasma level within 3 hours compared to pre-infusion (IU/dL)\]/{\[exact dose of component in drug administered (IU)\]/\[body weight (kg)\]}. |
| Secondary | Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | From preinfusion until 24 h after the start of infusion | Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal. |
| Secondary | Percentage of Participants With INR Correction at Various Times After the Start of Infusion | From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion. | The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion. |
| Secondary | Percentage of Participants With INR Correction at Various Times After Randomization | From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization. | The time taken from randomization to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization. |
| Secondary | Transfusion of Red Blood Cells | From the start of infusion until 24 h after the start of infusion | Red blood cells were packed red blood cells (PRBCs). |
| Secondary | Use of Other Blood Products and Hemostatic Agents | From the start of infusion until 24 h after the start of infusion | Other blood products and hemostatic agents containing coagulation factors (such as whole blood, plasma, albumin, platelets) not including PRBCs. |
| Secondary | 45-Day All-cause Mortality | Until Day 45 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed | At 1 and 4 hours after the end of infusion | The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, presented with acute major bleeding, and had an international normalized ratio (INR) \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR) | 30 minutes after end of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding | At 3 and 6 hours after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex | Before infusion and up to 3 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | (IU/dL)/(IU/kg body weight) | MEAN |
| SECONDARY | Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | From preinfusion until 24 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of normal | MEAN |
| SECONDARY | Percentage of Participants With INR Correction at Various Times After the Start of Infusion | From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion. | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With INR Correction at Various Times After Randomization | From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization. | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Transfusion of Red Blood Cells | From the start of infusion until 24 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | Units of PRBCs | MEAN |
| SECONDARY | Use of Other Blood Products and Hemostatic Agents | From the start of infusion until 24 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | Units of blood products | MEAN |
| SECONDARY | 45-Day All-cause Mortality | Until Day 45 | The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed | Beriplex® P/N | 72.4 | 95% Confidence Interval 63.6 to 81.3 | percentage of participants | |
| Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed | Fresh Frozen Plasma | 65.4 | 95% Confidence Interval 56.2 to 74.5 | percentage of participants | |
| Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR) | Beriplex® P/N | 62.2 | 95% Confidence Interval 52.6 to 71.8 | percentage of participants | |
| Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR) | Fresh Frozen Plasma | 9.6 | 95% Confidence Interval 3.9 to 15.3 | percentage of participants | |
| Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding | Beriplex® P/N | 73.5 | 95% Confidence Interval 64.7 to 82.2 | percentage of participants | |
| Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding | Fresh Frozen Plasma | 67.3 | 95% Confidence Interval 58.3 to 76.3 | percentage of participants | |
| Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex | Beriplex® P/N | Factor II | 2.00 | Standard Deviation 0.879 | (IU/dL)/(IU/kg body weight) |
| Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex | Beriplex® P/N | Factor VII | 2.15 | Standard Deviation 2.958 | (IU/dL)/(IU/kg body weight) |
| Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex | Beriplex® P/N | Factor IX | 1.29 | Standard Deviation 0.711 | (IU/dL)/(IU/kg body weight) |
| Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex | Beriplex® P/N | Factor X | 1.96 | Standard Deviation 0.871 | (IU/dL)/(IU/kg body weight) |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Beriplex® P/N | 107 | |
| Overall Study | STARTED | Fresh Frozen Plasma | 109 | |
| Overall Study | COMPLETED | Beriplex® P/N | 82 | |
| Overall Study | COMPLETED | Fresh Frozen Plasma | 92 | |
| Overall Study | NOT COMPLETED | Beriplex® P/N | 25 | |
| Overall Study | NOT COMPLETED | Fresh Frozen Plasma | 17 |
Source ClinicalTrials.gov
Adverse events170
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 | Oedema peripheral | General disorders | Beriplex® P/N | 6 | 103 | 6 |
| other | Oedema peripheral | General disorders | Fresh Frozen Plasma | 7 | 109 | 7 |
| other | Pyrexia | General disorders | Beriplex® P/N | 4 | 103 | 4 |
| other | Pyrexia | General disorders | Fresh Frozen Plasma | 4 | 109 | 4 |
| other | Chest pain | General disorders | Beriplex® P/N | 2 | 103 | 2 |
| other | Chest pain | General disorders | Fresh Frozen Plasma | 3 | 109 | 3 |
| other | Headache | Nervous system disorders | Beriplex® P/N | 10 | 103 | 10 |
| other | Headache | Nervous system disorders | Fresh Frozen Plasma | 4 | 109 | 4 |
| other | Dizziness | Nervous system disorders | Beriplex® P/N | 4 | 103 | 4 |
| other | Dizziness | Nervous system disorders | Fresh Frozen Plasma | 0 | 109 | 0 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Beriplex® P/N | ||
| Total, all-cause mortality | Fresh Frozen Plasma | ||
| Total, other adverse events | Beriplex® P/N | 46 | 103 |
| Total, other adverse events | Fresh Frozen Plasma | 40 | 109 |
| Total, serious adverse events | Beriplex® P/N | 32 | 103 |
| Total, serious adverse events | Fresh Frozen Plasma | 26 | 109 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23935011 | RESULT |
Source PubMed
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 |
|---|---|
| Beriplex® P/N vs Fresh Frozen Plasma: 45-Day All-cause Mortality | Trial comparisons |
| Beriplex® P/N vs Fresh Frozen Plasma: 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00708435
GET https://conductscience.org/api/trials/v1/NCT00708435/results?page=2