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Growth Hormone Therapy for Wasting in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00803179
Recruitment Status : Terminated (Poor enrollment, patients were lost to follow up)
First Posted : December 5, 2008
Results First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Michael Stalvey, University of Massachusetts, Worcester

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cystic Fibrosis
Intervention Drug: Nutropin AQ
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Growth Hormone Therapy
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Nutropin AQ:

Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d

Period Title: Overall Study
Started 5
Completed 2
Not Completed 3
Reason Not Completed
Lost to Follow-up             3
Arm/Group Title Growth Hormone Therapy
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Nutropin AQ:

Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
0
   0.0%
Male
5
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy
Hide Description [Not Specified]
Time Frame 14 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Therapy
Hide Arm/Group Description:

Nutropin Aqueous (AQ):

Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy
Hide Description [Not Specified]
Time Frame 14 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Growth Hormone Therapy
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Nutropin AQ:

Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d

All-Cause Mortality
Growth Hormone Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Growth Hormone Therapy
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Growth Hormone Therapy
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michael Stalvey, MD, Principal Investigator
Organization: UMass Medical School
Phone: 508-856-4280
Responsible Party: Michael Stalvey, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00803179     History of Changes
Other Study ID Numbers: 900005
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: November 13, 2012
Results First Posted: January 15, 2013
Last Update Posted: January 15, 2013