A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-14

Study Completion Date

2020-01-01

Brief Summary

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To evaluate the effectiveness of rhGH (Recombinant human growth hormone) injection for improving motor development in patients with PWS.

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Detailed Description

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Conditions

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Prader-Willi Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rhGH injection/Jintropin AQ

Drug: Recombinant Human Growth Hormone Injection /Jintropin AQ, 30IU/10 mg/3ml/kit, 0.5 mg/m2/d for the first 4 weeks, then 1.0 mg/m2/d for subsequent 48 weeks; by subcutaneous injection, once per day for total 52 weeks.No control.

Group Type EXPERIMENTAL

Recombinant Human Growth Hormone (rhGH) Injection

Intervention Type DRUG

Drug: Recombinant Human Growth Hormone Injection /Jintropin AQ, 30IU/10 mg/3ml/kit, 0.5 mg/m2/d for the first 4 weeks, then 1.0 mg/m2/d for subsequent 48 weeks; by subcutaneous injection, once per day for total 52 weeks.

Interventions

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Recombinant Human Growth Hormone (rhGH) Injection

Drug: Recombinant Human Growth Hormone Injection /Jintropin AQ, 30IU/10 mg/3ml/kit, 0.5 mg/m2/d for the first 4 weeks, then 1.0 mg/m2/d for subsequent 48 weeks; by subcutaneous injection, once per day for total 52 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1.Signed informed consent from legal guardian of the subjects;
* Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures;
* Diagnosed as PWS by gene test;
* Age: 1 month (30 days after birth) - 5 years of age;
* Male or female;
* Calculated by Peabody Developmental Motor Scale, total motor quotient, gross motor quotient or fine motor quotient is less than 90 points;
* Thyroid function is within the normal reference range or remained within the normal reference range by substitution therapy;
* No history of rhGH therapy before.

Exclusion Criteria

* Subjects with abnormal liver or kidney function;
* Subjects with obvious central sleep apnea and/or moderate or severe obstructive sleep apnea, acute lung infection;
* Subjects with chronic diseases that have long-term effects on bone metabolism and body composition;
* Subjects with congenital skeletal dysplasia, or spine scoliosis with moderate and above degree requiring treatment or lameness;
* Subjects with history of congenital heart disease, or an echocardiogram showing that the structural abnormalities require surgery or interventional therapy or that the left ventricular ejection fraction is \<40%, or the abnormal electrocardiogram requiring intervention;
* Subjects with history of convulsions or epilepsy;
* Subjects with other systemic chronic diseases;
* Subjects with diagnosed tumors;
* Subjects with family history of cancers, a previous history of cancer, or considered to be a high risk of cancer combinating other information;
* Subjects with mental disease;
* Subjects with diabetes, or abnormal fasting glucose and researchers believe that may affect the safety of the subject;
* Subjects with severe obesity;
* Subjects with highly allergic constitution or allergy to proteins or investigational product or its excipient;
* Subjects who took part in other clinical trials within 3 months ;
* Subjects who received drug treatment that may interfere with GH secretion or GH action within 3 months;
* Other conditions in which the investigator preclude enrollment into the study

Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No