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Nutropin AQ

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |Roche Holding AG|Trials Updated: Jun 9, 2008

Nutropin AQ target and mechanism

ModalitySmall molecule

Also known as Nutropin AQ [somatropin (DNA origin) injection]

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Nutropin AQ clinical trials

Nutropin AQ · 1 trial · 1 indication

Phase 2 1
NCT00079742A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic FibrosisCystic Fibrosis
COMPLETED68 Analytics
PHASE2COMPLETED
A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the safety and efficacy of Nutropin AQ in treating growth restriction and increasing lean body mass (LBM) in children with cystic fibrosis (CF) and growth restriction.

Secondary Endpoints

To evaluate the effects of Nutropin AQ treatment on pulmonary function, disease-related exacerbations, and exercise tolerance in children with CF and growth restriction.
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Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
Nutropin AQ [somatropin (DNA origin) injection]DRUG -
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Eligibility Criteria

Age Range5 Years to 13 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Ability of parent or legal guardian to provide written informed consent and, if applicable, pediatric assent and compliance with study assessments for the full duration of the study * Diagnosis of CF by sweat or genetic testing * Between the ages of 5 and 12 years for girls an...

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Competitive Landscape -Cystic Fibrosis 20 trials

Frequently asked questions about Nutropin AQ

What is Nutropin AQ?

Nutropin AQ is a somatropin (DNA origin) injection developed by Roche Holding AG. It has been studied in cystic fibrosis, specifically for the treatment of growth restriction in children with the condition. The formulation is given as an injection and was evaluated in a Phase 2 clinical trial.

What is Nutropin AQ used for in cystic fibrosis?

Nutropin AQ was studied for the treatment of growth restriction in children with cystic fibrosis. The Phase 2 trial enrolled children aged 5 years and older with cystic fibrosis. It was investigated as a treatment for growth restriction associated with the disease rather than as a therapy for the underlying lung condition itself.

Who makes Nutropin AQ?

Nutropin AQ is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the company associated with the drug's clinical development in cystic fibrosis. The asset is a somatropin (DNA origin) injection.

What phase is Nutropin AQ in?

Nutropin AQ is in Phase 2 development for cystic fibrosis. The single recorded trial, NCT00079742, is a completed Phase 2 study. The drug is investigational in this indication and is not described as approved for cystic fibrosis.

What clinical trials is Nutropin AQ in?

Nutropin AQ has been evaluated in one clinical trial, NCT00079742, titled A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis. It was a completed Phase 2 study that enrolled 68 participants aged 5 years and older. The trial was uncontrolled.

Is Nutropin AQ the same as Nutropin AQ [somatropin (DNA origin) injection]?

Yes, Nutropin AQ is also known as Nutropin AQ [somatropin (DNA origin) injection]. The bracketed form is the full descriptive name of the same product, identifying it as a somatropin (DNA origin) injection. Both names refer to the Roche Holding AG asset studied in cystic fibrosis.