NCT00838968

Brief Summary

The purpose of the study is to determine whether interferon-alpha is effective in the treatment of p48 Positive patients with HCC after curative resection.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Typical duration for not_applicable hepatocellular-carcinoma

Status
withdrawn

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 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

4.8 years

First QC Date

February 6, 2009

Last Update Submit

August 21, 2012

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomainterferon-alphap48

Outcome Measures

Primary Outcomes (1)

  • 5-years survival rate

    5 years

Study Arms (2)

interferon-alpha (IFN-alpha)

ACTIVE COMPARATOR

the interferon-alpha is intramuscular injected 3,000,000U three times a week for 18 months

Drug: interferon-alpha

control

NO INTERVENTION

no interventions were assigned

Interventions

interferon-alphaDRUG

interferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months

Also known as: Recombinant Human Interferon α1b for Injection, SINOGEN
interferon-alpha (IFN-alpha)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with p48 Positive who underwent a curative resection of HCC

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Interferon-alphaInjections

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Hui-chuan Sun, MD

    Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Liver cancer institute

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

January 1, 2008

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

August 23, 2012

Record last verified: 2012-08