FindTrial
Sign In

Antimicotyc prophylaxis with Amphotericina B in lypidic complex aerosol in GVHD patients under steroid treatment - GVHD 1

Antimicotyc prophylaxis with Amphotericina B in lypidic complex aerosol in GVHD patients under steroid treatment - GVHD 1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003005-14-IT
Enrollment
Unknown
Registered
2008-06-06
Start date
2010-12-30
Completion date
Unknown
Last updated
2014-05-19

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

Conditions

GVHD patients MedDRA version: 9.1 Level: LLT Classification code 10018799 Term: GVHD

Interventions

Trade Name: ABELCET Pharmaceutical Form: Solution for infusion INN or Proposed INN: Amphotericin B Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-

Sponsors

ASSOCIAZIONE MALATTIE SANGUE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients under allogenica transplant that evolve in GVHD with steroid treatment. >18 years 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Clinical History of mycotic infection. Amphotericina B ipersensibility. No compliance patients to the therapeutic program.

Design outcomes

Primary

MeasureTime frame
Main Objective: Amphotericina B efficancy in decreasing IFI rate in GVHD patients under steroid therapy;Secondary Objective: Amphotericina B safety and tolerance;Primary end point(s): Amphotericina B efficancy in decreasing IFI rate in GVHD patients under steroid therapy—

Countries

Italy

Outcome results

None listed

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