CLINICAL TRIALS PROFILE FOR NUTROPIN AQ

All Clinical Trials for Nutropin Aq

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00079742 ↗	A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis	Completed	Genentech, Inc.	Phase 2	2003-09-01	This is a Phase II, multicenter, randomized, controlled, open-label trial of the safety and efficacy of Nutropin AQ administered subcutaneously (SC) daily in prepubertal children with CF and growth restriction.
NCT00102258 ↗	Role of Nutrition and Hormones in Boys With Disordered Growth	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2005-01-19	This study will determine whether adding more calories to the diet helps boys with growth problems grow better while being treated with Nutropin, a growth hormone that is used to help children grow taller. The Food and Drug Administration has approved Nutropin for use in children who are very short. This study will examine whether giving nutritional supplements in addition to Nutropin can help children grow better than with Nutropin alone. Boys between 7 and 10 years of age who are very short and below average in weight, but are otherwise healthy may be eligible for this study. Candidates must qualify for Nutropin treatments to boost their growth. Boys will be recruited for the study from the Nemours Children's Clinic in Jacksonville, FL, and from the National Institutes of Health in Bethesda, MD. Participants are randomly assigned to one of two treatment groups. One group is observed for 6 months and then receives a Nutropin injection every day for 12 months. The second group drinks 8 ounces of a high-calorie beverage called Pediasure every day for 6 months and then receives Nutropin plus Pediasure every day for 12 months. In addition to treatment, participants undergo the following tests and procedures at the schedule indicated: Baseline, 3, 6, 9, 12, 15 and 18 months - Clinical examination - Height measurement - Body composition assessment: Skin-fold thickness calipers are used in four places on the body to estimate body fat - Bioelectric impedance: A small amount of electrical current is used to calculate the percentage of body fat. Baseline, 6, 12, and 18 months - Blood tests - Bone age x-ray: x-ray of the left hand to measure growth potential - DEXA (dual energy x-ray absorptiometry) scan: x-ray scan to measure body fat, muscle, and bone mineral content. The subject lies on a flat table during the scan. Baseline, 6, and 12 months - Record of dietary intake: Parents are asked to write down everything the child eats and drinks for 3 days. Using this record, a dietitian calculates the daily caloric intake. - Total energy expenditure: This test determines how much energy the child uses. For the test, the child drinks water labeled with harmless isotopes (heavy oxygen and heavy hydrogen). For the next 10 days he collects urine in plastic tubes at home. At the end of the 10 days, the parents bring the urine to the clinic for analysis to determine how fast the labeled water leaves the body. This information is used to calculate how much energy the child expends each day. Participants' weight is measured at 2 and 4 weeks, and then monthly for the remainder of the 18-month study.
NCT00134420 ↗	Growth Hormone and Chromosome 18q- and Abnormal Growth	Completed	Genentech, Inc.	Phase 3	2001-02-01	We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
NCT00134420 ↗	Growth Hormone and Chromosome 18q- and Abnormal Growth	Completed	South Texas Veterans Health Care System	Phase 3	2001-02-01	We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.

Clinical Trial Conditions for Nutropin Aq

Condition Name

Condition Name for Nutropin Aq
Intervention	Trials
Growth Hormone Deficiency	4
Cystic Fibrosis	2
Pseudohypoparathyroidism Type 1a	1
Female Infertility Due to Diminished Ovarian Reserve	1

Condition MeSH

Condition MeSH for Nutropin Aq
Intervention	Trials
Dwarfism, Pituitary	5
Endocrine System Diseases	2
Fibrosis	2
Cystic Fibrosis	2

Clinical Trial Locations for Nutropin Aq

Trials by Country

Trials by Country for Nutropin Aq
Location	Trials
United States	48

Trials by US State

Trials by US State for Nutropin Aq
Location	Trials
New York	5
Texas	4
Florida	4
Minnesota	3
Georgia	2

Clinical Trial Progress for Nutropin Aq

Clinical Trial Phase

Clinical Trial Phase for Nutropin Aq
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Nutropin Aq
Clinical Trial Phase	Trials
Withdrawn	4
Completed	4
Terminated	2

Clinical Trial Sponsors for Nutropin Aq

Sponsor Name

Sponsor Name for Nutropin Aq
Sponsor	Trials
Genentech, Inc.	5
University of Texas Southwestern Medical Center	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2

Sponsor Type

Sponsor Type for Nutropin Aq
Sponsor	Trials
Other	11
Industry	7
NIH	2

Nutropin AQ: Clinical Trials, Market Analysis, and Projections

Introduction

Nutropin AQ, a recombinant human growth hormone (hGH) produced by Genentech, Inc., is used to treat various growth disorders. This article will delve into the clinical trials, market analysis, and projections for Nutropin AQ, providing a comprehensive overview of its use, safety, and market dynamics.

Clinical Trials and Safety Profile

National Cooperative Growth Study (NCGS)

The National Cooperative Growth Study (NCGS) is a significant post-marketing surveillance program that has been monitoring the long-term safety and efficacy of Nutropin AQ, along with other growth hormone products, since 1985. This observational study has enrolled a large number of patients, including those with growth failure due to inadequate endogenous growth hormone secretion, Turner syndrome, and chronic renal insufficiency[4].

Adverse Reactions

Clinical trials and post-marketing surveillance have identified several adverse reactions associated with Nutropin AQ. Common adverse reactions include hypothyroidism, impaired glucose tolerance, headache, hypertonia, arthralgia, myalgia, and peripheral oedema. More serious adverse reactions reported include neoplasms (both malignant and benign), intracranial hypertension, and diabetes mellitus. Injection site reactions such as hemorrhage, atrophy, urticaria, and pruritus can also occur but can be mitigated by proper injection technique and rotation of injection sites[1][2].

Serious Adverse Reactions

Intracranial hypertension, typically associated with papilloedema, visual changes, headache, nausea, and/or vomiting, is a serious adverse reaction that usually occurs within eight weeks of initiating therapy. Neoplasms, including recurrences of previous neoplasms and second neoplasms, have also been reported in both clinical trials and post-marketing surveillance[1].

Indications and Usage

Nutropin AQ is indicated for several conditions:

• Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion
• Long-term treatment of growth failure associated with Turner syndrome
• Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation
• Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology[3][5].

Market Analysis

Market Dynamics

The market for human growth hormone products, including Nutropin AQ, is influenced by several factors such as patent law, regulatory approvals, cash flows, patient demographics, and pricing strategies. GlobalData's analysis takes into account these factors to create high-value models for evaluating the drug's potential[5].

Patient Population

The patient population for Nutropin AQ includes children and adults with growth hormone deficiency or related growth disorders. The demand for these products is driven by the need for effective treatments for these conditions, which are often lifelong.

Competitive Landscape

The market for growth hormone products is competitive, with several other recombinant hGH products available. Nutropin AQ competes with other brands such as Genotropin, Humatrope, and Saizen. The competitive landscape is shaped by factors like product efficacy, safety profile, pricing, and patient preference.

Projections and Future Outlook

Regulatory Approvals and Patent Law

The future market for Nutropin AQ will be influenced by regulatory approvals and patent law. As patents expire, generic versions of the drug may enter the market, potentially affecting the sales of the branded product. However, ongoing regulatory approvals for new indications can expand the market share[5].

Cash Flows and Pricing

The financial performance of Nutropin AQ is dependent on cash inflows from sales and outflows related to research, development, and marketing. Pricing strategies, including discounts and reimbursement policies, play a crucial role in determining the drug's profitability.

Market Growth

The global market for human growth hormone products is expected to grow, driven by increasing awareness of growth disorders, advancements in treatment options, and expanding patient populations. Nutropin AQ, with its established safety and efficacy profile, is well-positioned to capture a significant share of this growing market.

"GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates." - GlobalData[5]

Conclusion

Nutropin AQ is a well-established treatment for various growth disorders, backed by extensive clinical trials and post-marketing surveillance. Its safety profile, while including some serious adverse reactions, is generally favorable. The market for Nutropin AQ is influenced by regulatory, financial, and competitive factors, but it remains a significant player in the human growth hormone market.

Key Takeaways

• Clinical Trials: Nutropin AQ has been extensively studied in clinical trials and post-marketing surveillance, including the National Cooperative Growth Study (NCGS).
• Safety Profile: Common adverse reactions include hypothyroidism, impaired glucose tolerance, and injection site reactions. Serious adverse reactions include neoplasms and intracranial hypertension.
• Indications: Nutropin AQ is indicated for growth failure due to inadequate endogenous growth hormone secretion, Turner syndrome, chronic renal insufficiency, and adult growth hormone deficiency.
• Market Analysis: The market is influenced by regulatory approvals, patient demographics, and pricing strategies.
• Projections: The market for human growth hormone products is expected to grow, with Nutropin AQ positioned to capture a significant share.

FAQs

What is Nutropin AQ used for?

Nutropin AQ is used for the long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion, Turner syndrome, chronic renal insufficiency, and for replacing endogenous growth hormone in adults with growth hormone deficiency.

What are the common adverse reactions associated with Nutropin AQ?

Common adverse reactions include hypothyroidism, impaired glucose tolerance, headache, hypertonia, arthralgia, myalgia, and peripheral oedema.

What serious adverse reactions have been reported with Nutropin AQ?

Serious adverse reactions include neoplasms (both malignant and benign), intracranial hypertension, and diabetes mellitus.

How is Nutropin AQ administered?

Nutropin AQ is administered subcutaneously, available in both vial and pen cartridge forms.

What is the National Cooperative Growth Study (NCGS)?

The NCGS is a post-marketing surveillance program that collects long-term safety and efficacy information on growth hormone products, including Nutropin AQ.

Sources

1. European Medicines Agency. NutropinAq, INN-Somatropin - European Medicines Agency. [PDF]
2. FDA. Nutropin AQ® [somatropin (rDNA origin) injection]. [PDF]
3. European Medicines Agency. NutropinAq, INN-Somatropin - European Medicines Agency. [PDF]
4. Lake Clinical Trial. National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin.
5. GlobalData. Net Present Value Model: Nutropin AQ.