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Eltrombopag for Fanconi Anemia
Study Summary
This trial is testing a new drug, eltrombopag, to see if it is effective in people with Fanconi anemia. People with the disease often have reduced blood cell counts and may need transfusions. The trial will monitor participants closely for side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 3 trial • 92 Patients • NCT01520909Trial Design
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- I am at least 2 years old.I cannot take medicine by mouth.I have a heart condition that could make participating in the study unsafe.You have a history of abusing alcohol or drugs.I have been diagnosed with Fanconi anemia through genetic testing or chromosome analysis.You have a known allergy to EPAG or any of its parts.I am not pregnant or nursing.I am a sexually active male and agree to use a condom during the study and for 30 days after.You are very sick and likely to pass away within the next 7 to 10 days.I haven't taken androgens like danazol or oxymetholone in the last 4 weeks.I have a genetic mutation in both copies of my BRCA2 gene.I am cancer-free with no expected recurrence within a year.I have low blood counts or need regular blood transfusions.I have had blood clots in the past.My test shows genetic changes linked to a worse outlook in my condition.You weigh more than 10 kilograms.I have either not responded to or chosen not to take androgen therapy.I am a woman able to have children and am not using strong birth control methods.I have severe health issues that prevent me from taking eltrombopag.My condition meets the WHO criteria for MDS or AML.I have been diagnosed with HIV.Your creatinine levels are more than 2.5 times the normal limit.Your liver enzyme levels are more than 5 times the normal limit.My direct bilirubin level is higher than 3.0mg/dL.I have an infection that isn't getting better with treatment.My liver is severely damaged and my albumin levels are low.
- Group 1: Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What risks are associated with Eltrombopag consumption?
"There is limited data which attests to the safety of eltrombopag, hence it has been assigned a rating of 2. Unfortunately, efficacy results have yet to be gathered."
How many participants are partaking in this experimental research?
"Affirmative, the information on clinicaltrials.gov states that this experiment is presently recruiting participants. The proceedings were initially shared on November 2nd 2018 and was recently revised on September 22nd 2022. 35 patients must be enrolled at one facility for the trial to proceed."
Has enrollment for this experiment been opened up yet?
"Affirmative. According to clinicaltrials.gov, this research project has been actively recruiting since November 2nd 2018 and the last update was on September 22nd 2022. The study requires 35 participants from a single site."
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