Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar

Clinical Trial Summary

The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).

See also
	Status	Clinical Trial	Phase
	Completed	`NCT03749863` - Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT03749863 - Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05627648
Study type	Interventional
Source	Kringle Pharma, Inc.
Contact	Etsuro Hashimura
Phone	+81-72-641-8739
Email	hashimura@kringle-pharma.com
Status	Recruiting
Phase	Phase 3
Start date	November 24, 2022
Completion date	November 30, 2025

Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms