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Clinical Trial Summary

The purpose of this study is to assess the efficacy and tolerability of INSTYLAN (Sodium Hyaluronate 80mg/50ml) in Patients with early or late symptoms of moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy. The study is conducted in the field of routine clinical practice and will recruit 30 subjects treated with intravesical instillations with INSTYLAN weekly for 6 weeks.


Clinical Trial Description

This is a multicenter single-arm clinical study including male and female subjects with moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy as determined by the physician. A total of 30 subjects are anticipated and will be enrolled in 10 study sites in France. The patients will receive intravesical instillations with INSTYLAN weekly for 6 weeks. The objectives of the study are to assess the efficacy of intravesical instillations of INSTYLAN on the basis of hemorrhagic cystitis symptoms disappearance. The primary endpoint is the evaluation of pain using a verbal rating scale one week and four weeks after treatment versus Baseline. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04696666
Study type Interventional
Source LIDDE Therapeutics
Contact François SCHUTZE, PhD
Phone +33 (0)6 83 54 01 42
Email fr.schutze@liddetherapeutics.com
Status Recruiting
Phase N/A
Start date May 15, 2020
Completion date July 30, 2021

See also
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Recruiting NCT02174536 - A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis Phase 2
Terminated NCT04390113 - Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC) Phase 3
Not yet recruiting NCT06241274 - Moxibustion in the Treatment of Hemorrhagic Cystitis After Allo-HSCT N/A
Not yet recruiting NCT06198517 - Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT N/A
Recruiting NCT05726786 - The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial) Phase 3