An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis - Voriconazole in CF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006362-41-GB

Enrollment

Registered

2007-03-28

Start date

2007-04-05

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with cystic fibrosis MedDRA version: 8.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis

Interventions

Trade Name: Vfend Product Name: Vfend Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VORICONAZOLE CAS Number: 137234629

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Confirmed cystic fibrosis according to the US Cystic Fibrosis Foundation guidelines •Male or female subjects aged between 18 and 40 years; •Hospitalised subject requiring routine intravenous antibiotic treatment; •Written informed consent has been obtained; •Pancreatic insufficiency as determined by a faecal elastase of =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Known history or suspicion of alcohol or drug abuse; •Pregnancy or breast-feeding female; •Female subject of childbearing potential without adequate contraception; •Participation in an investigational drug trial in the 30 days prior to selection; •Known hypersensitivity to voriconazole or other azole (Fluconazole, Itraconazole, Ketoconazole, Ravuconazole, Posaconazole) antifungal agents; •Known history of severe drug allergy or hypersensitivity; •Has received systemic voriconazole within two weeks before study entry; •Is receiving treatment with drugs that are contraindicated (See Concomitant therapy); •Weight of less than 40kg •Has liver disease defined as liver enzymes > twice the upper normal limit or bilirubin > 50mmol/l at trial entry;

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoints of the trial are to determine the pharmacokinetic parameters for oral voriconazole and to determine if voriconazole serum levels >1.0mg L-1 are achieved in adult patients with cystic fibrosis using a standard oral dosing regimen.;Secondary Objective: The secondary endpoint of the trial is to determine if the frequency of adverse reactions and side-effects of oral voriconazole in adult patients with cystic fibrosis.;Primary end point(s): The primary endpoints of the trial are to determine the pharmacokinetic parameters for oral voriconazole and to determine if voriconazole serum levels >1.0mg L-1 are achieved in adult patients with cystic fibrosis using a standard oral dosing regimen.	—

Measure

Time frame

Main Objective: The primary endpoints of the trial are to determine the pharmacokinetic parameters for oral voriconazole and to determine if voriconazole serum levels >1.0mg L-1 are achieved in adult patients with cystic fibrosis using a standard oral dosing regimen.;Secondary Objective: The secondary endpoint of the trial is to determine if the frequency of adverse reactions and side-effects of oral voriconazole in adult patients with cystic fibrosis.;Primary end point(s): The primary endpoints of the trial are to determine the pharmacokinetic parameters for oral voriconazole and to determine if voriconazole serum levels >1.0mg L-1 are achieved in adult patients with cystic fibrosis using a standard oral dosing regimen.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026