A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 9, 2018

Estimated Primary Completion Date

May 6, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of Participants with suppression of GnRHa-stimulated luteinizing hormone (LH)(<4 milli-international units per milliliter (mlU/mL))[ Time Frame: At Week 24 ]

It is measured by peak LH stimulation test

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Percentage of Participants with suppression of GnRHa-stimulated luteinizing hormone (LH)(<4 mlU/mL)[ Time Frame: Up to Week 48 ]
It is measured by peak LH stimulation test
Percentage of female participants with suppression of basal estradiol to <20 pg/mL[ Time Frame: Up to Week 48 ]
Female participants with suppression of basal estradiol to < 20 pg/mL are assessed
Percentage of male participants with suppression of testosterone to <30 ng/dL[ Time Frame: Up to Week 48 ]
Male participants with suppression of testosterone to < 30 ng/dL are assessed
Percentage of participants with maintenance of suppression of GnRHa-stimulated LH (<4 mlU/mL)[ Time Frame: Up to Week 144 ]
Participants with maintenance of suppression of GnRHa-stimulated LH (<4 mlU/mL) are assessed
Percentage of female participants with maintenance of suppression of basal estradiol to <20 pg/mL[ Time Frame: Up to Week 144 ]
Female participants with maintenance of suppression of basal estradiol to < 20 pg/mL are assessed
Percentage of male participants with maintenance of suppression of testosterone to <30 ng/dL[ Time Frame: Up to Week 144 ]
Male participants with maintenance of suppression of testosterone to < 30 ng/dL are assessed
Percentage of participants with suppression of the physical signs of puberty[ Time Frame: Up to Week 144 ]
Breast development in females, testicular volume or genital development in males will be assessed using modified Tanner staging.
Incremental growth rate[ Time Frame: Up to Week 144 ]
Incremental growth rate (cm/year) will be assessed.
Ratio of change from baseline in bone age vs chronological age[ Time Frame: Up to Week 144 ]
Ratio of change from baseline in bone age vs chronological age is assessed

Descriptive Information

Brief Title ^ICMJE

A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

Official Title ^ICMJE

A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)

Brief Summary

The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Leuprolide Acetate (LA)
It is administered intramuscularly as an injection

Study Arms

Experimental: Participants receiving Leuprolide Acetate (LA)
Participants with Central Precocious Puberty receiving LA

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 1, 2022

Estimated Primary Completion Date

May 6, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

- Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age). - No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.

Sex/Gender

Sexes Eligible for Study:

All

Ages

2 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Puerto Rico|United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Yes

Responsible Party

，

Study Sponsor ^ICMJE

AbbVie

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: AbbVie Inc. AbbVie

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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