An interventional study of Liposomal amphotericin B and Amphotericin B-deoxycholate in Cryptococcal Meningitis, sponsored by TTY Biopharm. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-12.
Sponsored by TTY Biopharm · Not applicable, Interventional, and Treatment
To evaluate the safety and efficacy of liposomal amphotericin B and amphotericin B deoxycholate with or without flucytosine followed by fluconazole for the treatment of cryptococcal meningitis.
Subjects who meet all eligible requirements will be randomized into study group （Lipo-AB）or control group（Amphotericin B deoxycholate） in 2:1 ratio. Subjects will be treated with induction therapy in study group or in control group with flucytosine for at least 14 days, and followed by consolidation therapy for another 56 days after CSF sterilization.
54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.
This study's planned enrollment of 84 is below the median of 143 across 35 interventional studies indexed under Meningitis, Cryptococcal.
Browse Meningitis, Cryptococcal studies →TTY Biopharm is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Within 7 days prior to, or at the time of screening visit, patient with cryptococcus meningitis, diagnosed by :
Exclusion Criteria:
Patients have laboratory abnormalities within 3 days prior to screening visit :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Liposomal amphotericin B
Drug: Amphotericin B-deoxycholate
4mg/kg/day, IV infusion
Also known as: Lipo-AB
1mg/kg/day, IV infusion
Also known as: Amphotericin B
suscceful response rate
Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.
Time frame: Day 14
This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal amphotericin B
TTY Biopharm