A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients

NCT06595069 | Completed

• 1 other identifier: CKJX839A1CN05
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single-center, retrospective, observational study (non-interventional study with secondary use of data) among patients in a real-world setting. This study used the medical record data from patients in Yiling. Eligible patients who newly initiated inclisiran from 26 January 2022 to 21 August 2023 were included. The retrospective data up to the date of ethics committee approval (April 2024) was collected. The study team collected patient data using an electronic case report form (eCRF) from April 2024 to June 2024.

Conditions

Hypercholesterolemia

Keywords

Elevated low-density lipoprotein cholesterol; Inclisiran; Real-world

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels

  Baseline, Month 9

Secondary Outcomes (15)

• Absolute Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels

  Baseline, Month 9

• Change From Baseline to Month 9 in Total Cholesterol Levels

  Baseline, Month 9

• Change From Baseline to Month 9 in Apolipoprotein B Levels

  Baseline, Month 9

• Change From Baseline to Month 9 in non-High Density Lipoprotein Cholesterol Levels

  Baseline, Month 9

• Change From Baseline to Month 9 in Serum Apolipoprotein A1 Levels

  Baseline, Month 9

Study Arms (1)

Inclisiran Cohort

Chinese adult patients who received at least one treatment with inclisiran.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Received at least one inclisiran injection during the indexing period.
• Had at least 9 months of follow-up from the index date (had at least one LDL-C assessment during baseline period and at least one LDL-C assessment at 9 months or later).
• Patients signed the informed consent form.

You may not qualify if:

• Participated in any blinded interventional clinical studies anytime during the study period.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: April 30, 2024
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)