GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: Details of ATryn phase-2 trial in DIC/sepsis

I’ve reposted the most consequential sections of
the clinicaltrials.gov entry below. Worthy of note
is that the primary endpoint of this phase-2 study is
survival at day 28 with an improvement in the DIC
score and no worsening in the organ-failure score.
As GTC has mentioned, this trial is not powered
to show a survival benefit per se. (That will be the
job of the phase-3 trials.) Other notable details are
that the trial will have 200 patients randomized into
four arms (presumably three ATryn arms and a
control arm) and that the trial site in the UK is
already recruiting patients.

>>
The primary objective of the study is to explore the efficacy and safety of ATryn® for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.

Study Design: Randomized, Open Label, Active Control

Number of arms in study: 4

Primary Outcome Measure: Patients alive on day 28 having had an improvement in DIC score and having had no worsening on organ failure score.

Secondary Outcome Measures: Mortality at 28 and 90 days. Change in organ failure score and DIC score. Pharmacokinetic (PK) parameters.

Total Enrollment: 200

Study start: July 2007; Expected completion: October 2008

Eligibility: Ages 18 Years and above, both genders

Inclusion Criteria:

• Signed informed consent has been obtained from the patient or his/her legally acceptable representative
• Severe sepsis
• Disseminated intravascular coagulation
• Predicted mortality between 30 and 60%

Location and Contact Information:

Canada

Charles Lemoyne Hospital, Quebec, J4V 2H1, Canada; Not yet recruiting

Germain Poirier, MD, Principal Investigator
[phone] Ext. 2880 [e-mail]


France

Service de Réanimation Polyvalente, CHRU Hôpital Roger Salengro, Lille Cedex, 59037, France; Not yet recruiting

Francois Fourrier, MD, Principal Investigator
[phone] [e-mail]


Germany

Abteilung Anästhesiologie II - Operative Intensivmedizin, Georg-August-Universität Göttingen, Göttingen, 37075, Germany; Not yet recruiting

Michael Quintel, MD, Principal Investigator
[phone] [e-mail]


United Kingdom

Critical Care Unit, University College Hospital, London, NW1 2BU, United Kingdom; Recruiting

Geoff Bellingan, MD, Principal Investigator
[phone] [e-mail]

[Dr. Bellingan is the Principal Investigator of the entire trial.]
<<