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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05431803




Registration number
NCT05431803
Ethics application status
Date submitted
20/06/2022
Date registered
24/06/2022

Titles & IDs
Public title
Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China
Scientific title
Real-World Study of Lanreotide Autogel for the Treatment of Patients With Acromegaly in China
Secondary ID [1] 0 0
CLIN-52030-455
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants achieving full biochemical control
Timepoint [1] 0 0
At 12 months
Secondary outcome [1] 0 0
Percentage of participants achieving fasting GH < 1 µg/L and IGF-1 normalization
Timepoint [1] 0 0
At 12 months
Secondary outcome [2] 0 0
Percentage of participants achieving fasting GH =2.5 µg/L and IGF-1 =1.3 Upper Limit of Normal (ULN)
Timepoint [2] 0 0
At 12 months
Secondary outcome [3] 0 0
Mean change in fasting GH and IGF-1 concentrations.
Timepoint [3] 0 0
From baseline to 3, 6, and 12 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
From baseline to 6 and 12 months
Secondary outcome [5] 0 0
Mean change in Quality of Life (QoL) scores
Timepoint [5] 0 0
From baseline to 6 and 12 months
Secondary outcome [6] 0 0
Treatment utilisation of LAN, evaluated by the total number of injections received
Timepoint [6] 0 0
From baseline to 12 months
Secondary outcome [7] 0 0
Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)
Timepoint [7] 0 0
From baseline to 12 months
Secondary outcome [8] 0 0
Incidence of all Adverse Events (AEs)
Timepoint [8] 0 0
From baseline to 3, 6 and 12 months
Secondary outcome [9] 0 0
Mean change in physical examination results
Timepoint [9] 0 0
From baseline to 3, 6, and 12 months
Secondary outcome [10] 0 0
Mean change in vital signs blood pressure
Timepoint [10] 0 0
From baseline to 3, 6, and 12 months
Secondary outcome [11] 0 0
Mean change in vital signs heart rate
Timepoint [11] 0 0
From baseline to 3, 6, and 12 months
Secondary outcome [12] 0 0
Mean change in Clinical laboratory assessments
Timepoint [12] 0 0
From baseline to 6, and 12 months
Secondary outcome [13] 0 0
Mean change in free thyroxine (FT4) and cortisol for males and females
Timepoint [13] 0 0
From baseline to 6 and 12 months
Secondary outcome [14] 0 0
Mean change in testosterone for males only
Timepoint [14] 0 0
From baseline to 6 and 12 months
Secondary outcome [15] 0 0
Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only.
Timepoint [15] 0 0
From baseline to 6 and 12 months

Eligibility
Key inclusion criteria
* Participants who are able to comply with the protocol
* Participants with serum IGF-1 level above the ULN for age and sex, and serum fasting GH level above 2.5 µg/L
* Participants with acromegaly who are naïve to LAN treatment and about to initiate LAN
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who are currently participating in any investigational study or clinical trial of acromegaly
* Pregnant participants
* Participants with hypersensitivity to somatostatin or related peptides or to any of the excipients

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Changsha
Country [3] 0 0
China
State/province [3] 0 0
Chengdu
Country [4] 0 0
China
State/province [4] 0 0
Guangzhou
Country [5] 0 0
China
State/province [5] 0 0
Hangzhou
Country [6] 0 0
China
State/province [6] 0 0
Nanjing
Country [7] 0 0
China
State/province [7] 0 0
Shenyang
Country [8] 0 0
China
State/province [8] 0 0
Shijiazhuang
Country [9] 0 0
China
State/province [9] 0 0
Wenzhou
Country [10] 0 0
China
State/province [10] 0 0
Wuhan
Country [11] 0 0
China
State/province [11] 0 0
Zhengzhou

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical, Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
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.
Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05431803