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Immunosuppressant

LP-10 for Hemorrhagic Cystitis

Phase 2
Waitlist Available
Research Sponsored by Lipella Pharmaceuticals, Inc.
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 at every patient visit, up to 2 weeks following initial treatment
Awards & highlights

Study Summary

This trial will assess the safety and tolerability of three doses of LP-10 (intravesical tacrolimus). 12 subjects will be enrolled and treated in a prospective and multi-center trial. 4 subjects will be allocated into each one of three groups.

Eligible Conditions
  • Hemorrhagic Cystitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at every patient visit, up to 2 weeks following initial treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at every patient visit, up to 2 weeks following initial treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient Reported Mean episodes of visible blood
Secondary outcome measures
Bladder Cystoscopy
Blood chemistry and liver function test
Incidence of Treatment-Emergent Adverse Events
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: LP-10 8mgExperimental Treatment1 Intervention
LP-10 (intravesical tacrolimus), 8mg reconstituted in sterile water for injection, intravesical instillations, up to two instillations, instillations will occur greater than 3 days but less than 7 days apart as needed.
Group II: LP-10 4mgExperimental Treatment1 Intervention
LP-10 (intravesical tacrolimus), 4mg reconstituted in sterile water for injection, intravesical instillations, up to two instillations, instillations will occur greater than 3 days but less than 7 days apart as needed.
Group III: LP-10 2mgExperimental Treatment1 Intervention
LP-10 (intravesical tacrolimus), 2mg reconstituted in sterile water for injection, intravesical instillations, up to two instillations, instillations will occur greater than 3 days but less than 7 days apart as needed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LP-10
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Lipella Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
75 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial available in many healthcare establishments within the state?

"Nine locations across the US are participating in this trial, including University of Arizona at Tucson, Emory University in Atlanta, and Vanderbilt University Medical Center near Nashville."

Answered by AI

Are there opportunities to join this clinical experiment?

"As of today, the trial is open to participants. Clinicaltrials.gov records indicate that it was first posted on October 1st 2020, with a more recent update taking place in October 24th 2022."

Answered by AI

Has the LP-10 drug been given official sanction by the FDA?

"LP-10 has been deemed to have an estimated safety rating of 2 as it is currently in Phase 2 trials, meaning there exists evidence of its security but not yet enough data on efficacy."

Answered by AI

What is the total sample size for this clinical trial?

"The sponsor of the trial, Lipella Pharmaceuticals, Inc., requires 12 patients that meet their criteria to participate in this medical investigation. Two locations where it is being carried out are at University of Arizona located in Tucson and Emory University found in Atlanta."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Emory University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis
2020. "The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03129126.
~3 spots leftby May 2025
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