NCT03266042

Brief Summary

Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

4 years

First QC Date

August 22, 2017

Last Update Submit

September 7, 2018

Conditions

Hepatic Malignant Neoplasm Primary Non-Resectable

Outcome Measures

Primary Outcomes (1)

  • Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).

    Data to be collected at: Baseline, treatment and post treatment laboratory values and clinical measurements until time of discharge

    Post-procedure (up to 30 days after CS-PHP)

Secondary Outcomes (4)

  • Percentage of treatment with CHEMOSAT each patient receives

    From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed]

  • Evaluation of Best Overall Response

    from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months]

  • Evaluation of resource utilization

    From the first CHEMOSAT treatment through the last CHEMOSAT treatment [assessed up to 24 months]

  • Evaluate time to treatment failure

    time from first CHEMOSAT treatment to the date of last CHEMOSAT treatment [assesed up to 24 months]

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received or will receive treatment with CHEMOSAT for the Treatment of Unresectable Hepatic Malignancy

1. Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT. 2. Have provided written informed consent according to institutional and regulatory guidelines

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Southampton University Hospitals and University of Southampton

Southampton, United Kingdom

RECRUITING

Spire Southampton Hospital

Southampton, United Kingdom

RECRUITING

Central Study Contacts

Leslie Callahan, BSN, MS

CONTACT

212-489-2100lcallahan@delcath.com

Nathalie Riebel, MBA

CONTACT

212-489-2100nriebel@delcath.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 29, 2017

Study Start

January 14, 2016

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

GB(2)