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A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427958
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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).

Condition or disease Intervention/treatment Phase
Puberty, Precocious Drug: Leuprorelin Phase 4

Detailed Description:

The drug in this study is called leuprorelin. It is administered as a 1 month subcutaneous depot injection. Leuprorelin is used to treat children who have CPP. This study will look at whether leuprorelin can stop early puberty in pre-pubertal children.

The study will enroll approximately 300 participants. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty
Actual Study Start Date : August 7, 2015
Actual Primary Completion Date : November 23, 2018
Actual Study Completion Date : November 23, 2018


Arm Intervention/treatment
Experimental: Leuprorelin
Participants with body weight greater than or equal to (>=) 20 kilogram (kg) will receive the recommended dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (<) 20 kg will receive leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks.
Drug: Leuprorelin
Suspension for injection.
Other Name: Enantone




Primary Outcome Measures :
  1. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to Week 100 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Regression or no Progression in Tanner Staging at Week 96 [ Time Frame: Week 96 ]
    Tanner assessment score was used to document the stage of development of puberty through the assessment 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 was defined as negative change (improvement) or no change in Tanner score at Week 96 compared to baseline.



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Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. In the opinion of the investigator, the participant and/or parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
  2. The participant or the participant's parent(s) or legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  3. Has onset of appearance of secondary sexual characteristic earlier than age 8.0 years in girls or earlier than 9.0 years in boys and the symptom is persistent, and has confirmed diagnosis of CPP.
  4. Has basal luteinizing hormone (LH) level greater than (>) 5.0 international units per liter (IU/L) or peak LH >3.3 IU/L with LH/follicle-stimulating factor (FSH) >0.6 in stimulation test.
  5. Has evidence of gonadal development evaluated by ultrasonography: ovarian volume >=1 milliliter (mL) with multiple follicles >=4 millimeter (mm) in any ovary or uterine enlargement in females or testicular volume >=4 mL in males.
  6. Has advanced bone age (BA) >=1 year and BA is less than or equal to (<=) 11.5 years in females or <=12.5 years in males OR predicted adult height <150 centimeter (cm) in females or <160 cm in males OR standard deviation score (SDS) <-2 standard deviations (SD) OR rapid growth defined as growth of BA /growth of chronologic age >1. BA is determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards at screening.
  7. Has anticipated treatment duration of at least 2 year in investigator's judgment.
  8. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 90 days after last dose.
  9. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
  10. The female participant who, at the discretion of the investigator, is deemed to be of child bearing potential must provide negative urine pregnancy text at Day -1 or Day 1 prior to drug administration.

Exclusion Criteria:

  1. Has received any investigational compound within 30 days prior to Screening.
  2. Has received gonadotropin-releasing hormone analog (GnRHa) treatment in a previous clinical study or as a therapeutic agent.
  3. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example [eg], spouse, parent, child, sibling) or may consent under duress.
  4. Has any findings in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.
  5. Has any concomitant medical condition that, in the opinion of the investigator, may expose a participant to an unacceptable level of safety risk or that affects participant compliance.
  6. Has any screening abnormal laboratory value that suggests a clinically significant underlying disease or condition that may prevent the participant from entering the study; or the participant has: creatinine >=1.5 milligram per deciliter (mg/dL), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN), or total bilirubin >2.0 mg/dL, with AST/ALT elevated above the limits of normal values.
  7. Has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease.
  8. Has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.
  9. Has a diagnosis of peripheral precocious puberty.
  10. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit.
  11. Participant or parent(s), at the discretion of the investigator, is unlikely to comply with the protocol or is unsuitable for any of other reason.
  12. If female, the participant is of childbearing potential (eg, not sterilized).
  13. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
  14. If male, the participant intends to donate sperm during the course of this study or for 90 days thereafter.
  15. Has participated in another clinical study and/or has received any investigational compound within 30 days prior to Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427958


Locations
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China, Beijing
Beijing, Beijing, China
China, Hubei
Wuhan, Hubei, China
China, Hunan
Changsha, Hunan, China
China, Jiangsu
Nanjing, Jiangsu, China
Wuxi, Jiangsu, China
China, Jiangxi
Nanchang, Jiangxi, China
China, Jilin
Changchun, Jilin, China
China, Shanghai
Shanghai, Shanghai, China
China, Zhejiang
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Statistical Analysis Plan  [PDF] June 1, 2017
Study Protocol  [PDF] December 16, 2015


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02427958     History of Changes
Other Study ID Numbers: Leuprorelin-4001
U1111-1183-0353 ( Registry Identifier: WHO )
CTR20140148 ( Registry Identifier: SFDA CTR )
First Posted: April 28, 2015    Key Record Dates
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases