A clinical trial to study the efficacy And Safety Of Octafibrin Compared To HaemocomplettanÂ® P/ Riastapâ?¢ In Subjects With Congenital Fibrinogen Deficiency.

Phase 2

Active, not recruiting

Conditions: Health Condition 1: null- Subjects with congenital fibrinogen deficiency.

Registration Number: CTRI/2013/09/003953

Lead Sponsor: Octapharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

1. Aged >=12 years

2. Documented congenital fibrinogen deficiency (afibrinogenaemia)

a. Plasma fibrinogen activity and antigen at screening bellow detection limit (i.e. <20mg/dl)

3. Informed consent signed by subject or legal guardian

Exclusion Criteria

1. Life expectancy <6 months

2. Bleeding disorder other than congenital fibrinogen deficiency

3. Dysfibrinogenemia

4. Treatment with:

a. Any fibrinogen concentrate or other fibrinogen-containing blood product in the 2 weeks prior to enrolment

5. Presence or history of:

a. Hypersensitivity to study medication

b. Deep vein thrombosis or pulmonary embolism within 1 year prior to enrolment

c. Arterial thrombosis within 1 year prior to enrolment

d. Hypersensitivity to human plasma proteins

6. Acute bleeding

7. History of oesophageal varicose bleeding

8. End-stage liver disease (i.e. Child-Pugh-score B or C)

9. Planned major surgery with a need for blood transfusion during the PK blood-sampling period of this study

10. Pregnancy, or the intention to become pregnant during the study

11. Currently breast-feeding, or with the intention of breast-feeding during the study

12. HIV positive with a viral load >200 particles/Î¼l approximately >400000 copies/ml

13. Polytrauma 1 year prior to enrolment

14. Suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery if available <0.5 (mg/dl)/(mg/kg), (there is currently no standard test for inhibitors)

15. Blood or plasma donation in the 3 months prior to enrolment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A comparison of the AUC and MCF between Octafibrin and HaemocomplettanÂ® PTimepoint: 1hour post-infusion.

Secondary Outcome Measures

Name	Time	Method
Comparison of the in vivo recovery before and after the single intravenous infusionTimepoint: within 4 hours after infusion;The comparison of pharmacokinetics which will be done through PK samplingTimepoint: 0.5,1,2,4,8 hours post infusion and at Day 2,3,5,7,10 and 14 post infusion consecutively. <br/ ><br>