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A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema

NCT02994771 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-04-24

No results posted yet for this study

Summary

Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer.

Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer.

Conditions

  • Secondary Lymphedema

Interventions

DRUG

Lymfactin® [1 x 10E10 vp]

Lymfactin® \[1 x 10E10 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL.

DRUG

Lymfactin® [1 x 10E11 vp]

Lymfactin® \[1 x 10E11 vp\] 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 · HUCH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-02-03
Completion
2022-04-05

Countries

  • Finland

Study Locations

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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 NCT02994771 on ClinicalTrials.gov