Trial Outcomes & Findings for Growth Hormone Therapy for Wasting in Cystic Fibrosis (NCT NCT00803179)
NCT ID: NCT00803179
Last Updated: 2025-12-02
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
14 months
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
Growth Hormone Therapy
Nutropin AQ:
Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Growth Hormone Therapy
Nutropin AQ:
Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Growth Hormone Therapy for Wasting in Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Growth Hormone Therapy
n=5 Participants
Nutropin AQ:
Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=121 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=121 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=121 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=121 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=121 Participants
|
PRIMARY outcome
Timeframe: 14 monthsPopulation: The study was stopped prematurely due to lack of enrollment and dropout. There was not sufficient number of individuals completing the study to perform an analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 monthsOutcome measures
Outcome data not reported
Adverse Events
Growth Hormone Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Stalvey, MD, Principal Investigator
UMass Medical School
Phone: 508-856-4280
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place