Coagulation Protein Disorders

Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)

NCT01053169 | PHASE 3 | OBSERVATIONAL

Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. This observational study was designed to evaluate the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding during surgery (perioperative bleeding) in a routine clinical setting.

6 Sites

445 Participants

Recruiting

16 Years to 55 Years

If interested, contact clinicaltrials@cslbehring.com for more information

CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy

Find closest sites:

SUBMIT

Royal Blackburn Hospital

Blackburn,United Kingdom

Blackpool

Blackpool,United Kingdom,FY38NR

Addenbrokes

Cambridge,United Kingdom,CB233RE

Royal Free Hospital

London,United Kingdom

Derriford Hospital

Plymouth,United Kingdom

Southhampton General Hospital

Southhampton,United Kingdom

Study Eligibility Criteria

Inclusion Criteria

IVIG-untreated subjects:
* Either subjects with newly diagnosed CIDP (developing over at least 2 months) or subjects with an IVIG treatment interruption for at least 1 year with a progressive disease (deteriorating in the last 2 months) prior to enrolment.
* Actual diagnosis (including electrophysiology) of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline.
* Age ≥18 years.
* Male or female.
* Written informed consent for study participation obtained before undergoing any study specific procedures.
IVIG-pretreated subjects:
* Being treated regularly with IVIG on a fixed cycle length of 2 to 6 weeks ± 5 days in the last 6 months, on a fixed dosage of ± 20 % in the last 6 months and deteriorating by at least 1 INCAT score point during the Washout Period of up to 10 weeks (except for an increase from 0 to 1 solely due to upper limb score).
* Historic diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria for definite or probable CIDP according to EFNS/PNS guideline.
* Age ≥18 years.
* Male or female.
* Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion Criteria

* Treatment with prothrombin complex concentrates (PCCs) other than Beriplex® P/N
* Acquired deficiency of the vitamin K-dependent coagulation factors (e.g., as induced by treatment with oral vitamin K antagonists)

Additional Studies

Additional studies can be found at ClinicalTrials.gov