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TTI-101 for Idiopathic Pulmonary Fibrosis
Phase 2
Recruiting
Research Sponsored by Tvardi Therapeutics, Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 12
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and tolerable for treating IPF over 12 weeks.
Who is the study for?
This trial is for people with idiopathic pulmonary fibrosis (IPF) who have a life expectancy of at least 12 months, can maintain oxygen levels with minimal support, and have not had significant IPF improvement in the past year. They should be on a stable dose of nintedanib or off it for 6 weeks, and meet certain lung function criteria.Check my eligibility
What is being tested?
The study tests TTI-101's safety and tolerability against a placebo over 12 weeks. Participants will take TTI-101 orally every day to see how well they tolerate it and if there are any benefits in treating IPF.See study design
What are the potential side effects?
While specific side effects of TTI-101 aren't listed here, common ones for new oral medications may include gastrointestinal issues like nausea or diarrhea, potential liver enzyme changes, fatigue, skin reactions or headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with an Adverse Event (AE)
Secondary outcome measures
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101
Maximum Observed Plasma Concentration (Cmax) of TTI-101
Time of Maximum Observed Plasma Concentration (tmax) of TTI-101
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: TTI-101 800 mg/dayExperimental Treatment1 Intervention
Participants will receive 800 mg/day of TTI-101 BID for 12 weeks.
Group II: TTI-101 400 mg/dayExperimental Treatment1 Intervention
Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.
Group III: TTI-101 1200 mg/dayExperimental Treatment1 Intervention
Participants will receive 1200 mg/day of TTI-101 BID for 12 weeks.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive a matching placebo BID for 12 weeks.
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Who is running the clinical trial?
Tvardi Therapeutics, IncorporatedLead Sponsor
4 Previous Clinical Trials
255 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken pirfenidone in the last 3 months.I do not have any lung diseases that would affect my participation in the study.I am scheduled for surgery during the study period.I might have a lung transplant during the study.I have taken more than 10 mg/day of steroids in the last 2 weeks.I had a chest scan within the last year that confirms I have IPF.I haven't had a lung infection or a severe IPF flare-up recently.My lung condition has improved in the last year, shown by tests.My lung function tests show I breathe well enough.I have been on a stable dose of nintedanib for 3 months or have not taken it for 6 weeks.I do not have any major health issues that would stop me from completing this study.I have been on a stable dose of nintedanib for at least 3 months, or I stopped it 6 weeks ago.I have a condition that affects my ability to swallow or absorb medications.I was diagnosed with IPF within the last 7 years according to recent guidelines.Your oxygen level is at least 88% when measured with a device that clips on your finger, and you need no more than 2 liters of oxygen per minute.I was diagnosed with IPF within the last 5 years.Your lungs can transfer oxygen well, with a certain level of diffusing capacity during screening.My lung function tests show I can breathe well enough for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: TTI-101 800 mg/day
- Group 2: TTI-101 1200 mg/day
- Group 3: Placebo
- Group 4: TTI-101 400 mg/day
Awards:
This trial has 0 awards, including: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.
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