Cystic FibrosisPhase 2NCT00079742
A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis
A Phase 2 study testing Nutropin AQ [somatropin (DNA origin) injection] in people with Cystic Fibrosis, run by Genentech, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Nutropin AQ [somatropin (DNA origin) injection]
- Type of treatment
- Injection or infusion
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to May 2007
- Phase
- Phase 2
- 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 and 5 and 13 years for boys
- Ability to perform pulmonary function tests in a reproducible manner, per American Thoracic Society guidelines for spirometry
- Height <= 10th percentile for age and sex
- Prepubertal, Tanner Stage 1
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- Bone age of the non-dominant hand and wrist obtained no more than 6 months prior to study entry (bone age must be <= 10 years for girls and <= 11 years for boys as read using the method of Greulich and Pyle)
- Adequate caloric intake (following the CFF guidelines is encouraged; caloric intake must be documented at screening using a 24-hour food diary)
- Normal thyroid function
Who cannot join
- Prior or current rhGH use
- History of short stature due to GHD
- History within the 12 months prior to screening of glucose intolerance (impaired glucose tolerance) or CF-related diabetes (CFRD) as defined by at least one of the following: fasting serum glucose of >= 126 mg/dL on two or more occasions; fasting serum glucose of >= 126 mg/dL plus any casual (previously called random) glucose level >= 200 mg/dL; casual (previously called random) glucose of >= 200 mg/dL on two or more occasions; fasting serum glucose of <= 126 mg/dL but 2-hour post oral glucose load of 140-199 mg/dL (impaired glucose tolerance) on two or more occasions; if a subject meets the criteria for impaired glucose tolerance or CFRD in the screening glucose tolerance test, even if there is no history of impaired glucose tolerance, the subject will not be eligible for the study.
- Infection with Burkholderia cepacia
- Qualitative change in antibiotic treatment (e.g., for exacerbation of lung infection) within 14 days of study entry
- Hospitalization or treatment with systemic corticosteroids during the 30 days prior to study entry
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- Inability to adhere to previously documented adequate nutrition
- Active neoplasia
- Participation in any other investigational study (including investigational drug studies) within 30 days of enrollment or during the study if in the treatment arm, except for participation in observational and questionnaire studies (untreated)
- Subjects who require, as part of the their medical care, scheduled elective hospitalizations for IV antibiotic therapy
About this study
Official title: A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of the Safety and Efficacy of Nutropin AQ [Somatropin (DNA Origin) Injection] for the Treatment of Growth Restriction in Children With Cystic Fibrosis
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Nutropin AQ [somatropin (DNA origin) injection]
- Keywords
- Growth restriction in children with cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutropin AQ [somatropin (DNA origin) injection]Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
To evaluate the effects of Nutropin AQ treatment on pulmonary function, disease-related exacerbations, and exercise tolerance in children with CF and growth restriction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2004 (estimated)
- Study startSep 2003
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 68 participants (actual)
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
- NCT00079742
- Sponsor's protocol ID
- L2762g
- Status last verified
- Jun 2008
- First submitted
- 11 Mar 2004
- Last updated
- 9 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of the Safety and Efficacy of Nutropin AQ [Somatropin (DNA Origin) Injection] for the Treatment of Growth Restriction in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00079742
- Acronym / sponsor ID
- L2762g
- Conditions
- Cystic Fibrosis
- Keywords
- Growth restriction in children with cystic fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- May 2007 (actual)
- First posted
- 16 Mar 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 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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 and 5 and 13 years for boys
- Ability to perform pulmonary function tests in a reproducible manner, per American Thoracic Society guidelines for spirometry
- Height <= 10th percentile for age and sex
Key exclusion criteria (10 listed)
- Prior or current rhGH use
- History of short stature due to GHD
- History within the 12 months prior to screening of glucose intolerance (impaired glucose tolerance) or CF-related diabetes (CFRD) as defined by at least one of the following: fasting serum glucose of >= 126 mg/dL on two or more occasions; fasting serum glucose of >= 126 mg/dL plus any casual (previously called random) glucose level >= 200 mg/dL; casual (previously called random) glucose of >= 200 mg/dL on two or more occasions; fasting serum glucose of <= 126 mg/dL but 2-hour post oral glucose load of 140-199 mg/dL (impaired glucose tolerance) on two or more occasions; if a subject meets the criteria for impaired glucose tolerance or CFRD in the screening glucose tolerance test, even if there is no history of impaired glucose tolerance, the subject will not be eligible for the study.
- Infection with Burkholderia cepacia
- Qualitative change in antibiotic treatment (e.g., for exacerbation of lung infection) within 14 days of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutropin AQ [somatropin (DNA origin) injection] | Drug | – |
Primary outcome
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.
1 secondary outcome
To evaluate the effects of Nutropin AQ treatment on pulmonary function, disease-related exacerbations, and exercise tolerance in children with CF and growth restriction.
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 9 Jun 2008.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nutropin AQ [somatropin (DNA origin) injection] in people with Cystic Fibrosis, run by Genentech, Inc..
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 9 inclusion and 10 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 9 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
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 9 Jun 2008.