German Inclisiran Network: Retrospective Registry of Pati... | NCT05438069

Studies
German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany

NCT05438069

Sponsor

Jena University Hospital

Status

Unknown status

Last Update Posted

Jul 7, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Hypercholesterolemia

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 11, 2020Actual

Primary Completion Date

Dec 11, 2025Estimated

Completion Date

Dec 11, 2025Estimated

First Submitted Date

Jun 24, 2022

First Submission Date that Met QC Criteria

Jun 24, 2022

First Posted Date

Jun 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2022

Last Update Posted Date

Jul 7, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oliver Weingärtner, Clinical Professor, Jena University HospitalPrincipal Investigator

Lead Sponsor

Jena University HospitalOTHER

Collaborators

Name	Class
Universitätsklinikum Leipzig	OTHER
Charite University, Berlin, Germany	OTHER
Technische Universität Dresden	OTHER
Deutsches Herzzentrum Muenchen

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany

Detailed Description

The aim of this retrospective, multi-center analysis is to use individual patient data to determine the extent of the variability in LDL-C reduction in response to inclisiran administration in a real-world setting.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with elevated LDL-cholesterol (hypercholesterolemia)		Application of si RNA Inclisiran to reduce serum LDL-cholesterol levels.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LDL-C change	LDL-C change in mg/dL / mmol/L	3 months, 6 months, 12 months, 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran
patients 18 years and older

Exclusion Criteria:

- patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

-patients with elevated LDL-C levels (hypercholesterolemia), who are treated with the siRNA Inclisiran

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oliver Weingaertner, MD	Contact	+4936419324521		oliver.weingaertner@med.uni-jena.de
Martin Foerster, PhD	Contact	+4936419325818		martin.foerster@med.uni-jena.de

Overall Officials

Name	Affiliation	Role
Oliver Weingaertner, MD	Jena University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jena University Hospital	Recruiting	Jena			Germany

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data that will be shared:

Study protocol and individual participant data underlying the results reported in the project report or article, after deidentification. Documents will be available 3 months after publication for 3 years for researchers submitting a structured application, after approval by a committee. Data will be made available for all types of analyses that produce results in the approved application. Requests should be sent informally to oliver.weingaertner@med.uni-jena.de. A data agreement must be signed for access to the data.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

3 months after publication for 3 years

Access Criteria

Data that will be shared:

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided