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Pegvisomant for Growth Hormone Excess
Study Summary
This trial is testing the role of the drug pegvisomant in children and adolescents with gigantism. Eligible participants must be aged 2-18, have GH excess, and be unresponsive or ineligible for current treatments. The study will last 60 weeks and include several visits with medical history and physical exams, questionnaires, heart and liver tests, and blood and urine tests. Participants will also have an MRI and hand X-ray at the baseline and 12-month visits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 4 trial • 44 Patients • NCT01701973Trial Design
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Who is running the clinical trial?
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- I am willing to stop my current GH excess treatments for 6 weeks before starting pegvisomant.I am between 2 and 17 years old.My liver tests are three times above the normal range.I have been diagnosed with excess growth hormone.My growth hormone-secreting tumor did not respond well to surgery or radiation.I have been diagnosed with excess growth hormone.My growth hormone levels are higher than normal for my age and sex.You are currently taking opioid medications.
- Group 1: 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many test subjects are being approved for this experiment?
"That is accurate. The clinical trial is recruiting patients, as reflected on clinicaltrials.gov. This study was posted on October 21st, 2019, and was last updated on September 28th, 2020. They are seeking to enroll 140 individuals from 1 site."
If a patient is not yet 55, can they still qualify for the research?
"The trial's inclusion criteria state that the youngest age a patient can be is 2 years old, with the maximum age being 18."
Are there any health concerns that come with taking Pegvisomant?
"Pegvisomant has been determined to be a safe medication by our team, as it has received a score of 3. This score is given to Phase 3 drugs, which means that there is some data supporting efficacy and multiple rounds of data supporting safety."
What other scientific research has been published about Pegvisomant?
"Currently, there are 2 ongoing Pegvisomant clinical trials. 1 of these active research studies is in Phase 3. Although the majority of Pegvisomant trials take place in Bethesda, Maryland, there are 2 clinical trial sites."
Are participants being recruited for this trial at present?
"The trial is currently recruiting patients, as noted on clinicaltrials.gov. This page was originally created on October 21st, 2019 and was last updated on September 28th, 2020."
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