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Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

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ClinicalTrials.gov Identifier: NCT01575756
Recruitment Status : Completed
First Posted : April 11, 2012
Results First Posted : November 30, 2016
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Octapharma

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Congenital Fibrinogen Deficiency
Afibrinogenemia
Interventions: Biological: Octafibrin
Biological: Haemocomplettan® P or RiaSTAPTM

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM) Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once followed by Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once 45 days later.
Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA® Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once followed by Octafibrin/FIBRYGA® 70 mg/kg BW intravenously once 45 days later.

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM)   Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA®
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 

Period 2:   Treatment Period 2
    Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM)   Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA®
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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.

Baseline Measures
   Full Analysis Set 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.0  (12.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  68.2% 
Male      7  31.8% 


  Outcome Measures

1.  Primary:   Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

2.  Primary:   Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion   [ Time Frame: 1 hour post-treatment ]

3.  Secondary:   Fibrinogen Activity Normalized Area Under the Curve Unstandardized   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

4.  Secondary:   Fibrinogen Activity Normalized Area Under the Curve Standardized   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

5.  Secondary:   Maximum Plasma Concentration Normalized (Cmaxnorm)   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

6.  Secondary:   Maximum Plasma Concentration (Cmax) Unstandardized   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

7.  Secondary:   Maximum Plasma Concentration (Cmax) Standardized   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

8.  Secondary:   Incremental in Vivo Recovery   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

9.  Secondary:   Classical in Vivo Recovery   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

10.  Secondary:   Time to Reach Maximum Plasma Concentration (Tmax)   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

11.  Secondary:   Terminal Half-life (t½)   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

12.  Secondary:   Mean Residence Time (MRT)   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

13.  Secondary:   Clearance   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]

14.  Secondary:   Volume of Distribution at Steady State (Vss)   [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director of Clinical Operations
Organization: Octapharma USA
phone: 201 604-1149
e-mail: sylvia.werner@octapharma.com



Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01575756     History of Changes
Other Study ID Numbers: FORMA-01
First Submitted: April 9, 2012
First Posted: April 11, 2012
Results First Submitted: October 5, 2016
Results First Posted: November 30, 2016
Last Update Posted: March 9, 2018