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IGF-1 Therapy in Patients With Cystic Fibrosis
Plain-language guide to NCT00566241: phase 1 randomized trial of IGF-1 LR3 and Mecasermin (rhIGF-1), 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00566241
- Phase
- phase 1
- Status
- terminated early
- Start
- 2008-06
- Completion (planned or actual)
- 2012-06
- Participants
- 15 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Cystic Fibrosis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test IGF-1 LR3 and Mecasermin (rhIGF-1).
It had two arms (groups): IGF-1 (experimental) and Placebo (placebo comparator).
Recombinant human IGF-1.
Placebo.
The registry classes the interventions as drug.
Who Took Part
The registry lists 15 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosis of cystic fibrosis as proven by either sweat chloride or DNA analysis. Age \>= 18 yr. Tanner stage: Femake Breasts: 4-5 Male Genitalia: 4-5.
The full record lists 3 inclusion and 13 exclusion criteria; among the exclusions: diabetic retinopathy; obstructive sleep apnea; respiratory failure requiring mechanical ventilation.
How the Study Was Run
Design: randomized, crossover and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got IGF-1 LR3 and who got the comparison, which limits bias.
Each person switched between IGF-1 LR3 and the comparison at some point, usually with a gap in between.
Neither the participants nor the staff measuring them knew who was on IGF-1 LR3, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2008-06 with completion listed for 2012-06.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Body weight and body composition (time frame: 28 weeks).
It also tracked 2 secondary outcomes, for example Pulmonary function and Carbohydrate tolerance.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of IGF-1 LR3 and Mecasermin (rhIGF-1) in 15 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the IGF-1 LR3 compound page and the Mecasermin (rhIGF-1) compound page, all human trials.
Our Notes on the Compounds
IGF-1 LR3: A modified IGF-1 analog that escapes binding proteins, so it stays active ≥24 h.
Mecasermin (rhIGF-1): FDA-approved recombinant human IGF-1 for severe primary IGF-1 deficiency in children; distinct from IGF-1 LR3 and IGF-1 DES.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.