MedTrace Logo

Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)

NCT03658967 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-07-09

No results posted yet for this study

Summary

This study evaluates the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo. The study product will be administered in combination with a surgical lymph node transfer operation. In addition, the safety and tolerability of the Lymfactin® treatment will be evaluated.

Conditions

  • Secondary Lymphedema

Interventions

DRUG

Lymfactin® (1x10E11 vp)

Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL.

DRUG

Placebo

Placebo will be administered as a single dose via perinodal injection in a volume of 2 mL.

Sponsors & Collaborators

  • Herantis Pharma Plc.

    lead INDUSTRY

Principal Investigators

  • Anne Saarikko, MD, PhD · Helsinki University Central Hospital

  • Maria Mani, MD, PhD · Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-07
Primary Completion
2019-12-16
Completion
2024-10-23

Countries

  • Finland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

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 NCT03658967 on ClinicalTrials.gov