Trial · NCT01486927
An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
NCT01486927, Phase 2, Phase 3, Completed, CSL Behring; results first posted 2016-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A. Trials, record NCT01486927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01486927
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
- NCT number
- NCT01486927
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 175 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Hemophilia A
- Interventions
- rVIII-SingleChain, Octocog alfa
- First posted
- 2011-12-07
- Last updated
- 2016-08-09
- Other registries' IDs
- eudract:2011-002393-23
- Results first posted
- 2016-08-09
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Success | Up to 24 months | The investigator rated the efficacy of the treatment based on a 4-point rating scale "excellent, good, moderate or poor/no response". Efficacy ratings of "excellent" or "good" were considered treatment success for this end point; the percentage of bleeding events with a rating of excellent or good and the 95% confidence interval are presented. The denominator includes all treated bleeding events. The 95% confidence interval is based on a model to account for within-subject correlation. |
| Primary | Inhibitor Formation to FVIII | Up to 24 months | Number of subjects who develop inhibitors to FVIII |
| Primary | Annualized Spontaneous Bleeding Rate | Up to 24 months | The annualized spontaneous bleeding rate (AsBR) was derived for each subject as follows: 365.25\*(number of spontaneous bleeding episodes requiring treatment) / (observed treatment period of interest). |
| Primary | Treatment Success During the Peri-operative Surgical Sub-study | From the start of surgery through the post-operative recovery (generally up to 14 days after surgery) | Subjects received rVIII-SingleChain before and during surgery based on the type of surgery and the clinical status of the subject. The investigator rated the efficacy of the treatment based on a 4-point surgical treatment rating scale of "excellent, good, moderate or poor/no response". Efficacy ratings of "excellent" or "good" were considered treatment success for this end point. The rate of success, defined as the percentage of surgeries with a rating of excellent or good for hemostatic efficacy on the surgical treatment scale is presented for the Surgical Population, based on the total number of surgeries (N=16) as denominator. |
| Secondary | AUC0-∞ (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | AUC0-∞ (AUC from 0 extrapolated to infinity) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency. |
| Secondary | Cmax (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | Cmax of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency. |
| Secondary | Tmax (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after a single infusion of octocog alfa and rVIII-SingleChain. |
| Secondary | Half-life (t1/2) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion. | Half-life (t1/2) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. |
| Secondary | Mean Residence Time (MRT) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | Mean residence time (MRT) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. |
| Secondary | Clearance (Cl) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | Clearance (Cl) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Success | Up to 24 months | % bleeding events successfully treated | NUMBER | |
| PRIMARY | Inhibitor Formation to FVIII | Up to 24 months | participants | NUMBER | |
| PRIMARY | Annualized Spontaneous Bleeding Rate | Up to 24 months | Number of spontaneous bleeds per year | MEDIAN | |
| PRIMARY | Treatment Success During the Peri-operative Surgical Sub-study | From the start of surgery through the post-operative recovery (generally up to 14 days after surgery) | % of surgeries with successful treatment | NUMBER | |
| SECONDARY | AUC0-∞ (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | IU*h/dL | MEAN | |
| SECONDARY | Cmax (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | IU/dL | MEAN | |
| SECONDARY | Tmax (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | hours | MEDIAN | |
| SECONDARY | Half-life (t1/2) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion. | hours | MEAN | |
| SECONDARY | Mean Residence Time (MRT) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | hours | MEAN | |
| SECONDARY | Clearance (Cl) (Part 1) | Before infusion and at up to 10 time points within 72 hours of infusion | mL/h/kg | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Success | rVIII-SingleChain On-demand | 92.4 | 95% Confidence Interval 87.8 to 95.3 | % bleeding events successfully treated | |
| Treatment Success | rVIII-SingleChain Prophylaxis | 92.2 | 95% Confidence Interval 86.3 to 95.8 | % bleeding events successfully treated | |
| Treatment Success | rVIII-SingleChain | 92.3 | 95% Confidence Interval 88.9 to 94.8 | % bleeding events successfully treated | |
| Inhibitor Formation to FVIII | Recombinant Factor VIII (rFVIII) | 0 | participants | ||
| Annualized Spontaneous Bleeding Rate | rVIII-SingleChain On-demand | 11.73 | Inter-Quartile Range 2.8 to 36.5 | Number of spontaneous bleeds per year | |
| Annualized Spontaneous Bleeding Rate | rVIII-SingleChain Prophylaxis | 0.00 | Inter-Quartile Range 0.0 to 2.4 | Number of spontaneous bleeds per year | |
| Treatment Success During the Peri-operative Surgical Sub-study | rVIII-SingleChain Surgical | 100 | % of surgeries with successful treatment | ||
| AUC0-∞ (Part 1) | PK Population (Part 1) | Octocog alfa | 1550 | Standard Deviation 552 | IU*h/dL |
| AUC0-∞ (Part 1) | PK Population (Part 1) | rVIII-SingleChain | 2090 | Standard Deviation 650 | IU*h/dL |
| Cmax (Part 1) | PK Population (Part 1) | Octocog alfa | 116 | Standard Deviation 18.1 | IU/dL |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recombinant Factor VIII (rFVIII) | 174 | |
| Overall Study | COMPLETED | Recombinant Factor VIII (rFVIII) | 161 | |
| Overall Study | NOT COMPLETED | Recombinant Factor VIII (rFVIII) | 13 |
Source ClinicalTrials.gov
Adverse events13
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 | Headache | Nervous system disorders | Safety Population | 13 | 174 | 14 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Safety Population | 20 | 174 | 22 |
| other | Nasopharyngitis | Infections and infestations | Safety Population | 18 | 174 | 22 |
| serious | Ankle fracture | Injury, poisoning and procedural complications | Safety Population | 1 | 174 | 1 |
| serious | Blood uric acid increased | Investigations | Safety Population | 1 | 174 | 1 |
| serious | Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | Safety Population | 1 | 174 | 1 |
| serious | Hypersensitivity | Immune system disorders | Safety Population | 1 | 174 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Safety Population | 1 | 174 | 1 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Safety Population | 1 | 174 | 1 |
| serious | Suicidal ideation | Psychiatric disorders | Safety Population | 1 | 174 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Population | ||
| Total, other adverse events | Safety Population | 45 | 174 |
| Total, serious adverse events | Safety Population | 8 | 174 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27330001 | DERIVED |
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 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.
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/NCT01486927
GET https://conductscience.org/api/trials/v1/NCT01486927/registered?page=2