Statistical Review and Evaluation - RiaSTAP
Type/Application ID/Amendment #: STN 125317/0 Phase: 3
Title: Human Fibrinogen, Pasteurized, Haemocomplettan P
Proposed Use (Indication): Treatment of acute bleeding in patients with congenital fibrinogen deficiency
Sponsor: ZLB Behring
Fast Track Application: N/A
Gene Therapy, Somatic Cell Therapy or Xenotransplantation: N/A
Product name(s)/Product Type:
Fibrinogen, Pasteurized (Human)
Product Type: BLOOD /Sub type: PLASMA
NISHA JAIN (Primary Reviewer)
BORIS ZASLAVSKY (Biostatistics Reviewer)
IFTEKHAR MAHMOOD (Pharm/Tox Reviewer)
Cross-referenced INDs, IDEs, MFs, BLA: N/A
From: Boris Zaslavsky, Ph.D.
Through: Ghanshyam Gupta, Ph.D.
cc: HFM-215/Henry Hsu
Executive Summary: No statistical issues
Reviewer Title: Mathematical Statistician
Supervisor Title: Branch Chief
Concur ______________ Not Concur ______________
The primary objective of the study was to investigate the main pharmacokinetic properties of Human Fibrinogen Concentrate P in patients with primary fibrinogen deficiency (congenital afibrinogenaemia or severe congenital hypofibrinogenaemia).
Comment to CBER:
I found no clinical data related to efficacy and safety of the product in this submission. Please let me know if I have missed something.