Dwarfism, PituitaryNCT00097513
National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients
An observational study of Dwarfism, Pituitary, run by Genentech, Inc. at 1 site in United States.
Trial summary
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optimal GH dosing during puberty. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Dwarfism, Pituitary
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pubertal Growth Hormone Deficiency
Who may be able to join
- Adolescent boys who are GH deficient and Tanner Stage 2 or greater (testes 3 mL or greater)
- Adolescent girls who are GH deficient and breast Tanner Stage 2 or greater
- Current treatment with GH dose of 0.4 to 0.7 mg/kg/wk
- Ability to keep follow-up appointments throughout the study
- Willingness to remain on therapy until epiphyseal closure is achieved
- Prior enrollment in NCGS Core Study 85-036
Who cannot join
- Treatment with non-Genentech GH preparation
- Closed epiphyses
- Active neoplasia
- Treatment with insulin for diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Genentech Central Contact
South San Francisco, California, 94080
About this study
Official title: National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Subjects
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optimal GH dosing during puberty.
- Conditions
- Dwarfism, Pituitary
- Keywords
- Pubertal Growth Hormone Deficiency
- Medical subject headings
- Dwarfism, Pituitary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2004 (estimated)
- Study startFeb 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dwarfism, PituitaryStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barbara Lippe, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097513
- Sponsor's protocol ID
- 85-036, Substudy 12
- Status last verified
- Nov 2010
- First submitted
- 24 Nov 2004
- Last updated
- 15 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Subjects
- ClinicalTrials.gov ID
- NCT00097513
- Acronym / sponsor ID
- 85-036, Substudy 12
- Conditions
- Dwarfism, Pituitary
- Keywords
- Pubertal Growth Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Jun 2006 (actual)
- First posted
- 25 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optimal GH dosing during puberty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pubertal Growth Hormone Deficiency
Key inclusion criteria (6 listed)
- Adolescent boys who are GH deficient and Tanner Stage 2 or greater (testes 3 mL or greater)
- Adolescent girls who are GH deficient and breast Tanner Stage 2 or greater
- Current treatment with GH dose of 0.4 to 0.7 mg/kg/wk
- Ability to keep follow-up appointments throughout the study
- Willingness to remain on therapy until epiphyseal closure is achieved
Key exclusion criteria (4 listed)
- Treatment with non-Genentech GH preparation
- Closed epiphyses
- Active neoplasia
- Treatment with insulin for diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Lippe, M.D. study director
Genentech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dwarfism, Pituitary, run by Genentech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.