Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency

May 6, 2009 updated by: Altus Pharmaceuticals

A Twelve Month, Phase II, Randomized, Open-Label, Multi-Center, Dose-Ranging Study of Weekly ALTU-238 (Somatropin) as Compared With Daily Nutropin AQ (Somatropin) in Prepubertal Children With Growth Hormone Deficiency

The purpose of the study is to evaluate the safety and effectiveness of ALTU-238 in the treatment of children with growth hormone deficiency who have not yet reached puberty who lack the normal ability to make growth hormone themselves. This study will also test if ALTU-238 works as a weekly treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dr. Kenneth Attie, Medical Monitor
  • Phone Number: 781-373-6481
  • Email: kattie@altus.com

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
          • Dr Stephen Kemp
        • Principal Investigator:
          • Dr Stephen Kemp
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Nemours Children's Clinic
        • Contact:
          • Dr. Jorge Daaboul
          • Phone Number: 407-650-7210
        • Principal Investigator:
          • Dr. Jorge Daaboul
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Recruiting
        • Baystate Medical Centre
        • Contact:
          • Dr Edward Reiter
          • Phone Number: 413-794-5060
        • Principal Investigator:
          • Dr Edward Reiter
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Memorial Medical Center
        • Contact:
          • Dr. Leslie Soyka
          • Phone Number: 508-856-6289
        • Principal Investigator:
          • Dr. Leslie Soyka
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Contact:
          • Dr. Finen Ugrasbul
          • Phone Number: 816-234-3973
        • Principal Investigator:
          • Dr. Finen Ugrasbul
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Recruiting
        • Morristown Memorial Hospital
        • Contact:
          • Dr. Lawrence Silverman
          • Phone Number: 973-971-6340
        • Principal Investigator:
          • Dr. Lawrence Silverman
    • New York
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Schneider Children's Hospital
        • Contact:
          • Dr. Phyllis Speiser
          • Phone Number: 718-470-3290
        • Principal Investigator:
          • Dr. Phyllis Speiser
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Children's Hospital Medical Centre
        • Contact:
          • Dr Susan Rose
          • Phone Number: 513-636-4744
        • Principal Investigator:
          • Dr Susan Rose
    • Texas
      • Ft. Worth, Texas, United States, 76104
        • Recruiting
        • Cook Children's Hospital
        • Contact:
          • Dr. Paul Thornton
          • Phone Number: 682-885-7960
        • Principal Investigator:
          • Dr. Paul Thornton
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
          • Dr Patricia Fetchner
        • Principal Investigator:
          • Dr Patricia Fetchner
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Contact:
          • Dr. Gad Kletter
          • Phone Number: 206-215-2700
        • Principal Investigator:
          • Dr. Gad Kletter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Assent of subject, if applicable, and written informed consent of parent or legal guardian
  2. Diagnosis of GHD as defined by a maximum stimulated GH < 7 ng/mL (μg/L) on two stimulation tests (using any two distinct agents from the following list: arginine, L-dopa, clonidine, insulin, or glucagon); if two documented historical tests are not available,test(s) must be performed during Screening period
  3. Available results from one or more historical CT or MRI scans of the head obtained at or following the diagnosis of GHD
  4. Chronologic age at Screening of 3 to 13 years (inclusive) for boys and 3 to 12 years(inclusive) for girls
  5. Bone age at Screening of ≤ 11 years for boys and ≤ 10 years for girls
  6. Pre-pubertal at Screening (Tanner stage 1 for both breast/genitalia and pubic hair
  7. For subjects with idiopathic GHD, a Screening height SDS ≤ -2.0 (standardized for chronologic age and sex) there is no height SDS requirement if the subject has organic GHD (as defined by a CNS lesion or insult on a historical CT or MRI scan)
  8. Pre-treatment annualized height velocity ≤ median (50th percentile) for chronologic age and sex (based on values for delayed maturers provided in Appendix 4), utilizing Screening height and height obtained 52 ± 13 weeks (i.e. 39 to 65 weeks) prior to Screening
  9. Screening IGF-1 SDS for chronologic age and sex < -1
  10. If on thyroid hormone replacement therapy, the dose must be stable for at least 6 weeks prior to Screening and the free thyroxine level (T4), TSH, and cortisol must be within the normal range at the Screening visit

Exclusion Criteria:

  1. History of any prior rhGH, rhIGF-1, or sex steroid treatment
  2. History of treatment with any medications that may affect growth
  3. Evidence of active intracranial neoplasm per recent serial CT or MRI scans of the head or other criteria
  4. Surgery/chemotherapy/radiation therapy for intracranial neoplasm within the prior 52 weeks
  5. Any history of non-intracranial neoplasm
  6. History of or active benign intracranial hypertension
  7. High-dose chronic systemic corticosteroid treatment (oral or injected) within prior 13 weeks
  8. Acute or severe illness within prior 26 weeks
  9. History of diabetes mellitus, anorexia nervosa, cystic fibrosis, chronic severe kidney or liver disease, chronic infectious disease, inborn errors of metabolism, chromosomal disorders, intrauterine growth retardation, or other childhood disease associated with growth failure
  10. History of congenital syndromes associated with abnormal growth, including Turner syndrome, Noonan syndrome, Prader-Willi syndrome, etc.
  11. History of severe associated pathology affecting growth, including malnutrition,malabsorption, or bone dysplasia
  12. History of autoimmune disease
  13. Serum ALT or AST ≥ 1.5X ULN
  14. Participation in another clinical trial or treatment with any investigational agent (drug or biologic) within 30 days prior to Baseline if the half-life of the agent is known to be ≤ 6 days or within 6 weeks prior to Baseline if the half-life is > 6 days or not known
  15. History of any allergic or abnormal reaction to any of the components of the study drugs
  16. Any previous or ongoing clinically significant illness, PE findings, or laboratory abnormality that, in the opinion of the Investigator or the Medical Monitor, could prevent the subject from completing the protocol-specified requirements successfully
  17. Poor likelihood, in the Investigator's opinion, that the subject will comply with protocol requirements (e.g., uncooperative attitude, inability to return for follow-up visits, history of medical noncompliance) and/or poor likelihood of completing the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
ALTU-238
Drug: Somatropin
ALTU-238 0.3 mg/kg daily
Drug: Somatropin
ALTU-238 0.6 mg/kg daily
Drug: Somatropin
ALTU-238 0.9 mg/kg daily
Drug: Somatropin
Nutropin AQ 0.043 mg/kg daily
Experimental: 2
ALTU-238
Drug: Somatropin
ALTU-238 0.3 mg/kg daily
Drug: Somatropin
ALTU-238 0.6 mg/kg daily
Drug: Somatropin
ALTU-238 0.9 mg/kg daily
Drug: Somatropin
Nutropin AQ 0.043 mg/kg daily
Experimental: 3
ALTU-238
Drug: Somatropin
ALTU-238 0.3 mg/kg daily
Drug: Somatropin
ALTU-238 0.6 mg/kg daily
Drug: Somatropin
ALTU-238 0.9 mg/kg daily
Drug: Somatropin
Nutropin AQ 0.043 mg/kg daily
Active Comparator: 4
Nutropin AQ
Drug: Somatropin
ALTU-238 0.3 mg/kg daily
Drug: Somatropin
ALTU-238 0.6 mg/kg daily
Drug: Somatropin
ALTU-238 0.9 mg/kg daily
Drug: Somatropin
Nutropin AQ 0.043 mg/kg daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment
Time Frame: 26 Weeks
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Altus Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0001194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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