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AcromegalyNCT05431803

Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China

An observational study of Acromegaly, run by Ipsen at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acromegaly
How many people
129 participants
Where
12 sitesChina
Study dates
30 Jun 2022to 13 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult participants who have been diagnosed with acromegaly and initiating LAN treatment

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Peking Union Medical College Hospital (PUMCH)

    Beijing, 100000

  • Peking University Third Hospital (PUH3)

    Beijing, 100000

  • Xiangya Hospital Central South University (XYHCSU)

    Changsha, 410000

  • West China Hospital，Sichuan University (WCH)

    Chengdu, 610000

  • The First Affiliated Hospital,Sun Yat-sen University (FAHSYSU)

    Guangzhou, 510000

  • The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)

    Hangzhou, 310000

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (NJDTH)

    Nanjing, 210000

  • The First Hospital of China Medical University (CMU1H)

    Shenyang, 110000

  • The Second Hospital of Hebei Medical University (HB2H)

    Shijiazhuang, 050000

  • Affiliated Hospital of Wenzhou Medical University (FAHWMU)

    Wenzhou, 325000

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (TJH HUST)

    Wuhan, 430000

  • The First Affiliated Hospital of Zhengzhou University (FAHZZU)

    Zhengzhou, 450000

Other trials in China

About this study

Official title: Real-World Study of Lanreotide Autogel for the Treatment of Patients With Acromegaly in China

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.

Conditions
Acromegaly
Medical subject headings
Acromegaly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At 12 months

Secondary outcomes (15)

  1. Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization

    Measured: At 12 months

  2. Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN)

    Measured: At 12 months

  3. Mean change in fasting GH and IGF-1 concentrations.

    Measured: From baseline to 3, 6, and 12 months

  4. 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.

    Measured: From baseline to 6 and 12 months

  5. Mean change in Quality of Life (QoL) scores

    Assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL).

    Measured: From baseline to 6 and 12 months

  6. Treatment utilisation of LAN, evaluated by the total number of injections received

    Measured: From baseline to 12 months

  7. Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)

    Measured: From baseline to 12 months

  8. 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.

    Measured: From baseline to 3, 6 and 12 months

  9. Mean change in physical examination results

    Including Body Mass Index (BMI) and weight

    Measured: From baseline to 3, 6, and 12 months

  10. Mean change in vital signs blood pressure

    Measured: From baseline to 3, 6, and 12 months

  11. Mean change in vital signs heart rate

    Measured: From baseline to 3, 6, and 12 months

  12. 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

    Measured: From baseline to 6, and 12 months

  13. Mean change in free thyroxine (FT4) and cortisol for males and females

    Measured: From baseline to 6 and 12 months

  14. Mean change in testosterone for males only

    Measured: From baseline to 6 and 12 months

  15. Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only.

    Measured: From baseline to 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start30 Jun 2022
  3. Primary completion13 Dec 2024
  4. Study completion13 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431803
Sponsor's protocol ID
CLIN-52030-455
Status last verified
Jan 2025
First submitted
20 Jun 2022
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Acromegaly, run by Ipsen at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants achieving full biochemical control (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.

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