An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
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ClinicalTrials.gov Identifier: NCT01486927 |
Recruitment Status :
Completed
First Posted : December 7, 2011
Results First Posted : August 9, 2016
Last Update Posted : August 9, 2016
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Sponsor:
CSL Behring
Information provided by (Responsible Party):
CSL Behring
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Hemophilia A |
Interventions |
Biological: rVIII-SingleChain Biological: Octocog alfa |
Enrollment | 175 |
Participant Flow
Recruitment Details | This multicenter, multinational study enrolled subjects at 54 participating study centers in the United States, Japan, Europe, Australia, Canada, Lebanon, Malaysia, Philippines, Russian Federation, South Africa, and Ukraine. |
Pre-assignment Details | Screening took place 4 to 28 days prior to first dose of study product (rVIII-SingleChain). A total of 204 subjects were screened, 29 of these did not fulfill all eligibility criteria and were therefore screening failures. A total of 175 subjects were enrolled; 174 subjects were exposed to treatment with rVIII-SingleChain. |
Arm/Group Title | Recombinant Factor VIII (rFVIII) |
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In Part 1 of the study (a single-sequence crossover pharmacokinetic [PK] analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 exposure days (EDs). In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy. |
Period Title: Overall Study | |
Started | 174 |
Completed | 161 |
Not Completed | 13 |
Reason Not Completed | |
Knee surgery (prior to surgery substudy) | 1 |
Physician Decision | 1 |
50 Exposure days not reached | 2 |
Withdrawal by Subject | 8 |
Subject did not reach 6 mo of treatment | 1 |
Baseline Characteristics
Arm/Group Title | Recombinant Factor VIII (rFVIII) | |
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In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy. | |
Overall Number of Baseline Participants | 174 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 174 participants | |
31.3 (11.77) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 174 participants |
Adolescents (12-17 years) | 14 | |
Adults (18-65 years) | 160 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 174 participants | |
Female |
0 0.0%
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Male |
174 100.0%
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Type of FVIII product used before enrollment
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 174 participants |
Plasma-derived Product | 83 | |
Recombinant Product | 91 | |
[1]
Measure Description: Type of FVIII product used by the subjects before enrollment into the study. This could have been a plasma-derived FVIII product or a recombinant FVIII product.
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Treatment modality of FVIII therapy before enrollment
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 174 participants |
Prophylaxis | 82 | |
On-demand | 92 | |
[1]
Measure Description: Treatment modality of FVIII therapy before enrollment, ie, routine prophylaxis or on-demand treatment. If a subject used both modalities, only the most recent one was counted.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | Clinical Trial Disclosure Manager |
Organization: | CSL Behring |
Phone: | Use email contact |
EMail: | clinicaltrials@cslbehring.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT01486927 |
Other Study ID Numbers: |
CSL627_1001 2011-002393-23 ( EudraCT Number ) |
First Submitted: | November 19, 2011 |
First Posted: | December 7, 2011 |
Results First Submitted: | June 24, 2016 |
Results First Posted: | August 9, 2016 |
Last Update Posted: | August 9, 2016 |