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

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-PRC-13003130
• Date of registration: 2013-03-30
• Prospective Registration: Yes
• Primary sponsor: Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
• Public title: Voriconazole tablet for primary prophylaxis of invasive fungal infection in patients with severe aplastic anemia: a prospective, randomized, controlled, multi-center trial
• Scientific title: The efficacy and pharmacoeconimics of voriconazole tablet for primary prophylaxis of invasive fungal infection in patients with severe aplastic anemia
• Date of first enrolment: 2013-04-01
• Target sample size: Trial group:50;control:50;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=6429
• Study type: Prevention
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Kang Zhou
• Affiliation: Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

• Name: Fengkui Zhang

Key inclusion & exclusion criteria

Inclusion criteria: 1. naive patients meet the diagnostic criteria for V/SAA, and ANC<0.5*10^9/L;
2. aged 3-65 years old, male or female;
3. ECOG PS is 0-2;
4. no systemic or local fungal infections in 1 week;
5. serum TBIL level<=2 times ULN;
6. serum ALT and AST level<=2.5 times ULN;
7. plasma creatinine level<2 times ULNCcr>60ml/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: 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.

Age minimum: 3
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Severe Aplastic Anemia (SAA)

Intervention(s)

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.;control:without anti-fungal drug;

Primary Outcome(s)

Incidence of invasive fungal infection;

Secondary Outcome(s)

Drug-related adverse reaction;

Source(s) of Monetary Support

self-financing