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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Statistical Review and Evaluation - RiaSTAP

 Date: 31-JUL-08

 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

Review Team:
NISHA JAIN (Primary Reviewer)
BORIS ZASLAVSKY (Biostatistics Reviewer)
VASANTHA KUMAR
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
HFM-217/Ghanshyam Gupta
HFM-210/Steven Anderson
HFM-215/Chronological File

Executive Summary: No statistical issues

Reviewer Title: Mathematical Statistician
Reviewer Signature:
Review Date:

Supervisory Concurrence:

Supervisor Title: Branch Chief
Concur ______________ Not Concur ______________
Supervisory Signature:

Primary Objective:

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.

HFM- 219

CBER/OBE/DB