A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants

Takeda

Status: Completed

Conditions: Central Precocious Puberty

Treatments: Drug: Enantone; Drug: GnRH agonist

Study type: Observational

Funder types: Industry

Identifiers

NCT02993926

Leuprorelin-5001

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.

Full description

The drug being evaluated in this study is called Enantone (leuprorelin). Enantone is used to treat children who have CPP. This study will look at long term safety and efficacy of leuprorelin in the treatment of Chinese participants with CPP.

The study will enroll approximately 300 participants.

All participants who have received leuprorelin 30 mcg/kg to <90 mcg/kg or 90 mcg/kg to 180 mcg/kg per body weight, injection, subcutaneously, every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed.

This multi-center trial will be conducted in China. Data will be collected over period of 20 months.

Enrollment: 108 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has diagnosis of idiopathic CPP.
2. Has been treated with leuprorelin acetate (Enantone) for at least 9 continuous months of therapy with either a stable dose of high dose (greater than or equal to [>=] 90 mcg/kg up to 180 mcg/kg) or low dose (< 90 mcg/kg down to 30 mcg/kg).
3. Has initiated and completed treatment during the index period from September 1st 1998 to September 30th 2018.
4. Have the following information prior to initiation of enantone and at least one record of each of the following parameters at the end of enantone treatment in the medical records: Tanner staging, estradiol or testosterone level, and FSH and LH level. The participant should have at least one record of bone age prior to the initiation gonadotropin releasing hormone analogs (GnRHa) therapy with enantone to support the diagnosis of CPP. In addition, should have at least one record of bone age during treatment with enantone.

Exclusion criteria

1. Has been treated with leuprorelin acetate or any other GnRHa for conditions other than CPP.
2. Has used any other GnRHa products for CPP treatment prior to initiation of enantone therapy.
3. CPP participants with identified etiology, such as brain tumor or cranial irradiation.

Trial design

108 participants in 3 patient groups

Treatment Phase: Enantone

Description:

Participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).

Treatment:

Drug: Enantone

Follow Up: Participants No longer Treated for CPP

Description:

Participants who had completed their CPP during the treatment phase with Enantone and were no longer on treatment in the follow-up phase (the mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months).

Follow Up: Treated with Non-Enantone GnRHa after Enantone

Description:

Participants who were continuing their CPP treatment with a non-Enantone gonadotropin releasing hormone agonist (GnRHa) after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).

Treatment:

Drug: GnRH agonist