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NCT00381602 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis
A Phase 2 study, sponsored by QLT.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00381602 is a Phase 2 study that was terminated before completion, run by QLT. The registered enrollment target is 3 participants.
The verdict
NCT00381602, a Phase 2 study, was terminated before completion, sponsored by QLT.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG in subjects with ESRD on HD by following GH and IGF-1; to describe the relationship between GHRP-1 PD and plasma concentrations of GHRP-1 and des-Ala-GHRP-1; and to evaluate the preliminary efficacy of GHRP-1/AG on nutritional status of subjects with ESRD on HD using subjective global assessment of malnutrition inflammation scores (MIS) and changes in caloric intake.
Interventions
- OTHER Placebo
- DRUG GHRP-1/AG 70 mg depot in ESRD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00381602
The ClinicalTrials.gov registry entry for NCT00381602 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is QLT, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00381602 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00381602 about?
NCT00381602 is a clinical study titled "A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis". Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG in subjects with ESRD on HD by fo...
What is the current status of trial NCT00381602?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2006-09. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00381602?
The interventions under investigation include: Placebo (OTHER), GHRP-1/AG 70 mg depot in ESRD (DRUG).
Who is sponsoring clinical trial NCT00381602?
This trial is sponsored by QLT, which has 10 total clinical trials registered on ClinicalTrials.gov.
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