Skip to main content
MedPathMedPath Home
Clinical Trials/ISRCTN75734403
ISRCTN75734403
Completed
N/A

Comparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia (ALL)

Medac GmbH (Germany)0 sites32 target enrollmentJanuary 27, 2006
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Medac GmbH (Germany)
Enrollment
32
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 27, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Medac GmbH (Germany)

Eligibility Criteria

Inclusion Criteria

  • •1\. Previously untreated ALL
  • •2\. Morphological proof of ALL; bone marrow greater than 25% blasts
  • •3\. Aged 1 \- 18 years
  • •4\. Informed consent

Exclusion Criteria

  • •1\. Known allergy to ASNase
  • •2\. General health status according to Karnofsky/Lansky less than 40%
  • •3\. Pre\-existing coagulopathy (e.g. haemophilia)
  • •4\. Pre\-existing pancreatitis
  • •5\. Kidney insufficiency (creatinine greater than 220 umol/l)
  • •6\. Liver insufficiency (bilirubin greater than 50 umol/l; aspartate aminotransferase \[ASAT] and alanine aminotransferase \[ALAT] greater than 5 x upper limit of normal
  • •7\. Other current malignancies
  • •8\. Pregnancy, breast feeding
  • •9\. Patients suffering from mental disorders

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Phase 1
Comparative pharmacodynamics and pharmacokinetics study of generic and reference clopidogrel products in Thai Healthy volunteersAntiplatelet AgentsClopidogrelPlatelet inhibitionPlatelet aggregation
TCTR20131204001Khon Kaen University30
Completed
Phase 1
FarmaPEG-Ione. Healthy volunteers.Healthy Volunteers
RPCEC00000039Center for Genetic Engineering and Biotechnology (CIGB)16
Active, Not Recruiting
Phase 3
Comparative biosimilar rituximab vs Ristova in Rheumatoid ArthritisHealth Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
CTRI/2022/10/046212Virchow Biotech Private Limited
Completed
N/A
A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Low Body Weight versus Higher Body Weight Aspirin-Treated Subjects with Stable Coronary Artery DiseaseCoronary Artery Diseaseillness of coronary arteries10011082
NL-OMON34026Eli Lilly25
Active, Not Recruiting
N/A
A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel (LY640315) versus Clopidogrel in Subjects with Stable Atherosclerosis - TABR
EUCTR2005-005292-15-SEEli Lilly and Company Ltd.110