An observational study in Acromegaly, sponsored by Ipsen. Completed at 12 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by Ipsen · Observational
This study aims to assess the one-year effectiveness and safety of LAN among patients with acromegaly in China in routine clinical practice. In addition, the study is designed to understand the real-world treatment patterns and outcomes of LAN among Chinese patients with acromegaly.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's enrollment of 129 is above the median of 100 across 81 observational studies indexed under Acromegaly.
Browse Acromegaly studies →Ipsen is the lead sponsor of 289 studies on the registry; 17 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 22 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants who have been diagnosed with acromegaly and initiating LAN treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Percentage of participants achieving full biochemical control
Defined as fasting Growth Hormone (GH) ≤ 2.5 μg/L and Insulin-like Growth Factor-1 (IGF-1) normalization
Time frame: At 12 months
Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization
Time frame: At 12 months
Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN)
Time frame: At 12 months
Mean change in fasting GH and IGF-1 concentrations.
Time frame: From baseline to 3, 6, and 12 months
Mean change in the proportion of patients experiencing each of the symptoms (headache, excessive sweating, joint pain, fatigue, and soft tissue swelling) as evaluated by physicians.
Time frame: From baseline to 6 and 12 months
Mean change in Quality of Life (QoL) scores
Assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL).
Time frame: From baseline to 6 and 12 months
Treatment utilisation of LAN, evaluated by the total number of injections received
Time frame: From baseline to 12 months
Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)
Time frame: From baseline to 12 months
Incidence of all Adverse Events (AEs)
Including Serious Adverse Events (SAEs) and special situations assessed according to incidence, intensity, causality, outcome, action taken, and seriousness.
Time frame: From baseline to 3, 6 and 12 months
Mean change in physical examination results
Including Body Mass Index (BMI) and weight
Time frame: From baseline to 3, 6, and 12 months
Mean change in vital signs blood pressure
Time frame: From baseline to 3, 6, and 12 months
Mean change in vital signs heart rate
Time frame: From baseline to 3, 6, and 12 months
Mean change in Clinical laboratory assessments
Including fasting blood glucose, glycated hemoglobin A1C (HbA1c), total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL, and triglycerides
Time frame: From baseline to 6, and 12 months
Mean change in free thyroxine (FT4) and cortisol for males and females
Time frame: From baseline to 6 and 12 months
Mean change in testosterone for males only
Time frame: From baseline to 6 and 12 months
Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only.
Time frame: From baseline to 6 and 12 months
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Time frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Access criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Dec 2024, 29 months.
Of 26 observational studies under Acromegaly, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 263. This study's 29 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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