Clinical Trial: A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty

Brief Summary: The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty (CPP).

Detailed Summary:

The drug being tested in this study is called leuprorelin. It is administered as a 1 month subcutaneous depot. Leuprorelin is being tested to treat children who have CPP. This study will look at the development of internal and external genital organs and appearance of secondary sexual characteristics in pre-pubertal children who take leuprorelin.

The study will enroll approximately 300 patients. Participants with body weight >=20 kg will receive the recommended dose of leuprorelin 3.75 mg subcutaneous injection every 4 weeks for 96 weeks. Participants with body weight <20 kg will receive recommended dose of 1.88 mg subcutaneous injection every 4 weeks for 96 weeks.

This trial will be conducted in China. The overall time to participate in this study is 104 weeks. Participants will make 11 visits to the clinic, and will be followed-up by the physician on a long-term basis until stable puberty is reached.


Sponsor: Takeda

Current Primary Outcome: Number of Participants Reporting One or More Treatment-emergent Adverse Events [ Time Frame: Up to Week 100 ]

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.


Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of Participants who had Regression or no Progression in Tanner Staging [ Time Frame: Week 96 ]

Tanner assessment score is used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Regression or no progression is defined as negative change (improvement) or no change change in Tanner score at Week 96 compared to baseline.


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: April 23, 2015
Date Started: August 11, 2015
Date Completion: December 31, 2018
Last Updated: April 13, 2017
Last Verified: April 2017