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Clinical Trials/EUCTR2009-015403-95-CZ
EUCTR2009-015403-95-CZ
Active, Not Recruiting
Phase 1

A pilot trial of noninvasive assessment of methotrexate hepatotoxicity in the course of pharmacokinetically guided pharmacotherapy of psoriasis with methotrexate and folic acid

Faculty Hospital Hradec Králové0 sites90 target enrollmentOctober 7, 2009
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Conditionsmoderate-severe and severe plaque psoriasis
DrugsACIDUM FOLICUM LECIVAREMICADE 100 MGENBREL 50 MG

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
moderate-severe and severe plaque psoriasis
Sponsor
Faculty Hospital Hradec Králové
Enrollment
90
Status
Active, Not Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 7, 2009
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Faculty Hospital Hradec Králové

Eligibility Criteria

Inclusion Criteria

  • •\- patients with moderate\-severe or severe psoriasis requiring systemic immunosuppressive therapy
  • •\- patients had never received MTX or had not been taking MTX for at least 6 months preceding the study
  • •\- results of the laboratory tests without clinically significant alterations: Blood count (Hb, Hct, erythrocytes, leukocytes, differential blood count, platelets), Liver tests (ALT, AST, AP, g GT, albumin bilirubin), Creatinine/Urea, Urine sediment
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Desire to have children (for both men and women)
  • •Pregnancy and nursing
  • •Inadequate contraception
  • •Drug abuse
  • •Alcoholism
  • •Known sensitivity to active ingredient methotrexate (e.g. pulmonary toxicity)
  • •Dysfunction of the bone marrow
  • •Severe liver disease
  • •Severe infections
  • •Immunodeficiency

Outcomes

Primary Outcomes

Not specified

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