Cystic FibrosisPhase 2NCT00016445
Phase II Study of Growth Hormone in Children With Cystic Fibrosis
A Phase 2 study testing growth hormone in people with Cystic Fibrosis, run by University of Utah at 9 sites in United States.
Trial summary
OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis. II. Determine the effect of growth hormone on pulmonary function in these patients. III. Determine the impact of this drug on the quality of life in these patients. IV. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- growth hormone
- How many people
- 40 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2001to Aug 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 12 years
- All sexes
- No healthy volunteers
- Child
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Diagnosis of prepubertal cystic fibrosis
- No colonization by Burkholderia cepacia
--Prior/Concurrent Therapy--
- No prior or concurrent insulin requirement
--Patient Characteristics--
- Hematopoietic: No hematologic disease
- Hepatic: No liver disease
- Renal: No kidney disease
- Pulmonary: Must be able to perform pulmonary function testing
- Other: No history of diabetes Must be less than 25% of normal height and/or weight for age and sex
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Southwest Medical Center at Dallas
Dallas, Texas, 75390
Children's Medical Center - Dayton
Dayton, Ohio, 45404
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, 46202-5225
Children's Hospital of Orange County
Orange, California, 92868
Phoenix Children's Hospital
Phoenix, Arizona, 85006
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Washington University
St Louis, Missouri, 63110
T.L. Carey, M.D. and Associates
Tulsa, Oklahoma, 74136
About this study
OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis.
II. Determine the effect of growth hormone on pulmonary function in these patients.
III. Determine the impact of this drug on the quality of life in these patients.
IV. Determine if the clinical response from this drug is sustained in these patients.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive growth hormone subcutaneously (SC) daily for 1 year during the first year only.
Arm II: Patients receive growth hormone SC daily for 1 year during the second year only.
Quality of life is assessed at baseline and then every 6 months for 2 years.
- Conditions
- Cystic Fibrosis
- Being tested
- growth hormone
- Keywords
- cardiovascular and respiratory diseases, cystic fibrosis, disease-related problem/condition, genetic diseases and dysmorphic syndromes, quality of life, rare disease
- Medical subject headings
- Cystic Fibrosis, Respiratory Tract Diseases, Genetic Diseases, Inborn, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth hormoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2001 (estimated)
- Study startFeb 2001
- Primary completionAug 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 University of UtahThe 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Dana S. Hardin, Study chair, Southwest Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016445
- Sponsor's protocol ID
- 199/15806
- Other IDs
- UUSOM-IRB-7797-00, GENENTECH-UUSOM-IRB-7797-00
- Status last verified
- Sep 2008
- First submitted
- 6 May 2001
- Last updated
- 9 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Growth Hormone in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00016445
- Acronym / sponsor ID
- 199/15806
- Conditions
- Cystic Fibrosis
- Keywords
- cardiovascular and respiratory diseases, cystic fibrosis, disease-related problem/condition, genetic diseases and dysmorphic syndromes, quality of life, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Feb 2001
- Primary completion
- Aug 2007 (actual)
- First posted
- 7 May 2001 (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.
OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis.
II. Determine the effect of growth hormone on pulmonary function in these patients.
III. Determine the impact of this drug on the quality of life in these patients.
IV. Determine if the clinical response from this drug is sustained in these patients.
Detailed description
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive growth hormone subcutaneously (SC) daily for 1 year during the first year only.
Arm II: Patients receive growth hormone SC daily for 1 year during the second year only.
Quality of life is assessed at baseline and then every 6 months for 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| growth hormone | Drug | – |
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 9 Sep 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.
Dana S. Hardin study chair
Southwest Medical Center at Dallas
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing growth hormone in people with Cystic Fibrosis, run by University of Utah at 9 sites 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?
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 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
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.
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 Sep 2008.