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FP-045 for Fanconi Anemia
Phase 1 & 2
Recruiting
Research Sponsored by Foresee Pharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged 3-25
Documented Fanconi anemia by chromosome breakage analysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights
Study Summary
This trial is testing a new drug, FP 045, to see if it is safe and works well in treating patients with Fanconi anemia who have not had a bone marrow transplant. The trial will enroll 14-18 patients, who will each receive the drug at 3 different dose levels for 28 days each.
Who is the study for?
This trial is for young people aged 3-25 with Fanconi anemia and mild to moderate bone marrow failure. Participants must not have had a transplant or certain medical conditions, including active infections or liver issues. They should use effective birth control if applicable.Check my eligibility
What is being tested?
The study tests FP-045, given orally in escalating doses over three stages, each lasting 28 days. It aims to find the best dose and assess safety, how the body processes the drug (PK), and its initial effectiveness in treating Fanconi anemia.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at varying degrees related to digestive health, blood cell counts, potential liver function changes due to medication processing, and general discomforts like fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 3 and 25 years old.
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I have been diagnosed with Fanconi anemia through a specific genetic test.
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I have a mild to moderate decrease in blood cell production with at least one type of blood cell affected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Optimal Biologic Dose (OBP) of FP-045
stabilizing or improving cytopenia in FA
Secondary outcome measures
Safety and tolerability
pharmacokinetic profile
Trial Design
1Treatment groups
Experimental Treatment
Group I: FP-045Experimental Treatment1 Intervention
The study will enroll a total of 6 young adult/adolescent patients progressing through three dose levels, followed by a minimum of 8 and up to 12 pediatric patients progressing through up to three dose levels.
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Who is running the clinical trial?
Foresee Pharmaceuticals Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
733 Total Patients Enrolled
Susan M. Shelby, Ph.D.Study DirectorForesee Pharmaceuticals
Susan WhitakerStudy DirectorForesee Pharmaceuticals
1 Previous Clinical Trials
93 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a bone marrow or stem cell transplant.I have active Hepatitis B or C.I am receiving treatment for active graft versus host disease.I am between 3 and 25 years old.I need a strong CYP3A4 inhibitor medication.I have been diagnosed with myelodysplastic syndrome or acute leukemia.I have had cancer before, but it was only skin cancer or early-stage cervical cancer.I have a history of significant medical conditions.My liver enzymes are high or my kidney function is low.I have been diagnosed with Fanconi anemia through a specific genetic test.I have not had major surgery in the last 30 days.I have a mild to moderate decrease in blood cell production with at least one type of blood cell affected.I am currently fighting an infection in my body.
Research Study Groups:
This trial has the following groups:- Group 1: FP-045
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults aged 40 or older being recruited to take part in this trial?
"This medical trial is open to those aged 3-25 and have met the requirements for eligibility. 93 trials are available to patients under 18, with an additional 158 trials accessible for individuals who are over 65 years of age."
Answered by AI
Who meets the criteria for participating in this trial?
"Eligibility for this research necessitates that patients have diagnosed with Fanconi anemia and be between 3 to 25 years old. The trial is expected to recruit about 18 volunteers in total."
Answered by AI
Is this clinical experiment currently looking for volunteers?
"The clinicaltrials.gov database reveals that this medical experiment, which was initially put up on the 11th of November 2022, is not actively recruiting participants at present. Nonetheless, there are presently 225 other trials taking on new patients."
Answered by AI
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