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Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs

NCT04852679 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-10-01

Study results available
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Summary

This study will be conducted to support the registration of the lanreotide Autogel 120 mg formulation in China for the treatment of GEP-NETs and treatment of clinical symptoms of NETs.

The study will include a screening period of up to 4 weeks followed by a 48-week intervention period. After completion of the main study period, five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.

Conditions

  • Gastroenteropancreatic Neuroendocrine Tumor

Interventions

DRUG

Lanreotide autogel

Administered as deep subcutaneous (SC) injections

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2022-06-10
Completion
2023-01-13

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04852679 on ClinicalTrials.gov