Is NCT07221851 recruiting in Centennial, CO?

Yes, NCT07221851 is currently recruiting participants at its Centennial, CO location. This turner syndrome clinical trial is actively enrolling qualified participants.

How do I join the turner syndrome clinical trial in Centennial?

To join this clinical trial in Centennial, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Centennial clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Turner Syndrome Clinical Trial in Centennial, CO

About This Turner Syndrome Study in Centennial

This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \<18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.

Sponsor: Ascendis Pharma A/S

Who Can Participate

Inclusion Criteria

Chronological age between ≥2 and \<18 years, at start of screening.

Naïve to growth hormone and growth hormone promoting therapies.

Prepubertal.

Able to stand without assistance.

Diagnosis of TS, SHOX-D, SGA, or ISS with impaired growth or short stature, according to the following disease-specific criteria: TS or SHOX-D (Léri-Weill dyschondrosteosis):

Diagnosis confirmed by a genetic test. NOTE: Historical test results are acceptable for proof of diagnosis. For karyotypes, a minimum of 20 cells must be counted.

Impaired growth or short stature defined as: (i.) AHV \<25th percentile over a time span of 6-16 months prior to screening utilizing a historical height properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \<5th percentile for sex and age according to the Centers for Disease Control Growth Charts for the United States SGA without catch-up growth: c. Birth weight and/or birth length \< -2.0 SDS for gestational age according to the 2006 World Health Organization Child Growth Standards. For infants born premature, the Fenton Preterm Infant Growth Chart (Fenton 2013) should be used. d. Impaired growth or short stature defined as: (i.) AHV \<25th percentile over a time span of 6-16 months prior to screening properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \< -2.0 SDS for age and sex according to the 2000 Centers for Disease Control Growth Charts for the United States for children ≥ 3 years or height \< -2.5 SDS for age and sex according to the for children ≥ 2 years and \< 3 years ISS: e. Height \< -2.25 SDS for sex and age according to the Centers for Disease Control Growth Charts for the United States with no identifiable cause for short stature. f. Documented normal GH-IGF-1 axis, defined as either: (i.)IGF-1 SDS \>0 at screening based on central laboratory OR (ii.)Historical documentation of normal peak GH upon stimulation test (as defined by local institution) g. 46,XX chromosome as determined by karyotype or microarray if female. For karyotypes, a minimum of 30 cells must be counted.

If on hormone replacement therapies for any hormone deficiencies other than growth hormone (e.g., adrenal, thyroid), must be on adequate and stable doses for ≥4 weeks prior to and throughout screening.

Written, signed informed consent provided by parent(s) or legal guardian(s) of the participant. Assent should be signed by participant as required by IRB/HREC/IEC.

Exclusion Criteria

Advanced bone age X-ray by central reading defined as \>20% above chronological age in months (Greulich 1959).

Closed epiphyses as defined as bone age of ≥14.0 years in females or ≥16.0 years in males.

Current clinical diagnosis of diabetic retinopathy

Any diagnosis or presence at screening of the following:

Untreated moderate or severe sleep apnea as determined by formal (local) read of an inpatient or at-home sleep study.

Prader Willi syndrome with severe obesity, history of severe upper airway obstruction, or severe respiratory impairment.

Signs/symptoms of intracranial hypertension, active proliferative retinopathy.

Uncontrolled hypo- or hyperthyroidism.

Uncontrolled diabetes mellitus (defined as: HbA1c \>7.5% from central laboratory at screening).

Known history or diagnosis of any gastrointestinal inflammatory condition, HIV, radiation exposure, other skeletal dysplasias, growth hormone deficiency, and/or cardio-thoracic surgery due to their independent effects on growth.

Any significant hepatic or renal abnormality, such as abnormal renal function (defined as eGFR \<60 mL/min/1.73m2).

Undiagnosed or uncontrolled hypertension.

Receiving treatment with any agent that might influence growth or interfere with GH secretion or action including any sex steroids and stimulants for attention-deficit/hyperactivity disorder (ADHD).

High dose inhaled glucocorticoid for more than 28 consecutive days total over the course of 12 months.

Female who is pregnant, plans to be pregnant, or breastfeeding.

Participation in another interventional clinical trial involving an investigational compound within 90 days prior to screening or in parallel to this trial.

Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures.

Presence of Y chromosome material on genetic testing without history of gonadectomy.

Less than 10% of 45,X mosaicism.

Any known, clinically significant, congenital or acquired cardiovascular dysfunction that might interfere with growth.

Known history of any condition that causes disproportionate short stature (i.e. skeletal dysplasias), chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of gH receptors.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Centennial?

Yes, this clinical trial (NCT07221851) has an active research site in Centennial, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Turner Syndrome Treatment Options in Centennial, CO

If you're searching for turner syndrome treatment options in Centennial, CO, this clinical trial (NCT07221851) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Centennial research site is actively enrolling participants for this clinical trial. You'll receive care from experienced turner syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all turner syndrome clinical trials near you to find additional studies recruiting in your area.

Turner Syndrome Clinical Trial in Centennial, CO

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