Voriconazole tablet for primary prophylaxis of invasive fungal infection in patients with severe aplastic anemia: a prospective, randomized, controlled, multi-center trial

The efficacy and pharmacoeconimics of voriconazole tablet for primary prophylaxis of invasive fungal infection in patients with severe aplastic anemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-PRC-13003130

Enrollment

Unknown

Registered

2013-03-30

Start date

2013-04-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Severe Aplastic Anemia (SAA)

Interventions

control:without anti-fungal drug

Trial group:Vfend? (Voriconazole tablet for oral) should be administered 6mg/kg at the first day for adults, and then 200mg, twice daily

4-7mg/kg/d for children, divided into twice a day,with administration period no longer than 6 weeks.

Eligibility

Sex/Gender

All

Age

3 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. naive patients meet the diagnostic criteria for V/SAA, and ANC60ml/min; 8. serum myocardial enzyme level<2 times ULN; 9. patients are able to take medications orally; 10. patients or their guardian signed informed consent form before study.

Exclusion criteria

Exclusion criteria: 1. retreated patients; 2. history lasted over 3 months; 3. patients diagnosed with congenital aplastic anemia; 4. under 3 years old and above 65 years old; 5. active visceral or intracranial hemorrhage in 2 weeks; 6. usage of systemic antifungal drugs in recent 2 week; 7. patients with history of fungal infections; 8. complicated by systemic diseases affect study; 9. ECG: QTc>450ms(male), >470ms(female); 10. doppler echocardiography: LVEF<50%; 11. epilepsy and dementia receiving treatment, or other psychiatric diseases lead to noncooperate with investigators; 12. diseases uncontrolled (such as active heart disease, refractory diabetes mellitus, resistant hypertension, absorption abnormalities caused by GI tract dysfunction or Gastrointestinal illness); 13. allergic to element of the medicine; 14. attended other new drug clinical trials 4 weeks ago (including 4 weeks); 15. gestation or lactation; 16. conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinic site.

Design outcomes

Primary

Measure	Time frame
Incidence of invasive fungal infection;	—

Secondary

Measure	Time frame
Drug-related adverse reaction;	—

Countries

China

Contacts

Public ContactFengkui Zhang

zhfk@hotmail.com+86 22 23909229

Outcome results

None listed

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