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Trial · Interventional

TerminatedPhase 1Results postedRegistry data

Growth Hormone Therapy for Wasting in Cystic Fibrosis

NCTNCT00803179 (opens ClinicalTrials.gov in a new tab)Other id900005
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 1
Enrollment
5 participants (actual)
Sponsor
University of Massachusetts, Worcester · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Nov 2008
Primary completion
Mar 2012
Completion
Mar 2012
First posted
5 Dec 2008 (estimated)
Last update posted
2 Dec 2025
Conditions
Cystic Fibrosis

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 1

    Growth Hormone Therapy for Wasting in Cystic Fibrosis

    NCT00803179

    Nov 2008 to Mar 2012

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Our hypothesis is that Growth Hormone (GH) will not only target the peripheral tissue to stimulate weight and muscle growth which will maximize nutritional potential and improve overall quality of life. We theorize that this will occur through a multitude of factors: increased appetite, more constructive utilization of caloric intake and decreased catabolic signaling. The first aim will address changes in weight and lean body mass following the institution of GH therapy in adults with Cystic Fibrosis (CF) related wasting. The second aim will measure impact on quality of life of these individuals. Additionally, the third aim will monitor effects of GH therapy on diabetes and insulin sensitivity. Finally, the fourth aim will observe changes in the subjects underlying diagnosis of CF, specifically lung function, muscle strength and inflammatory state.

Interventions

  • Nutropin AQDrug

Arms1

  • Experimental

    Growth Hormone Therapy

    Nutropin Aqueous (AQ): Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy

    Time frame · 14 months

Secondary outcomes(1)

  1. Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy

    Time frame · 14 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 14 months

Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy

GroupValue
Growth Hormone Therapynot posted
Secondary and other outcome results(1)
Secondary outcome· 14 months

Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Growth Hormone TherapyNutropin AQ: Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d–0 / 50 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedThaker V, Carter B, Putman M. Recombinant growth hormone therapy for cystic fibrosis in children and young adults. Cochrane Database Syst Rev. 2021 Aug 23;8(8):CD008901. doi: 10.1002/14651858.CD008901.pub5. PMID 34424546

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Ability to provide written informed consent and comply with study assessments for the full duration of the study. * Age \> 18 years * Cystic fibrosis, diagnosed by either sweat chloride or genetic testing * Less than 92% ideal body weight based on body mass index (BMI) of 22 for women and 23 for men * Moderate or better pulmonary function (Forced Expiratory Volume (FEV1) \>40% of predicted). * Agree to use an effective method of birth control to prevent pregnancy during the research study. Women should not nurse (breast feed) a baby while on this study because Nutropin AQ may enter breast milk and possibly harm the child. Exclusion Criteria: * Pregnancy (positive pregnancy test) prior enrollment in the study * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Participation in another simultaneous medical investigation or trial * Pediatric patients * Active neoplasm * History of organ transplantation * Prader Willi Syndrome who are severely obese or have severe respiratory impairment * Patients with hepatic impairment resulting in abnormal coagulation studies (\>1.5 times normal reference range) * Poorly controlled diabetes as determined by a Hemoglobin A1c greater than or equal to 9.0%. * Individuals with electrocardiogram abnormality or cardiac pacing.

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