Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients

NCT ID: NCT02191540

Last Updated: 2014-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-05-31

Brief Summary

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Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion

Detailed Description

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Conditions

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Malignant Pleural Effusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abnoba Viscum F 20mg

Group Type EXPERIMENTAL

Abnoba Viscum F 20mg

Intervention Type DRUG

intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space

Interventions

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Abnoba Viscum F 20mg

intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space

Intervention Type DRUG

Other Intervention Names

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viscum album extract mistletoe extract abnobaVISCUM

Eligibility Criteria

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Inclusion Criteria

* Subject who need the pleurodesis among subjects diagnosed with a mlignant pleural effusion
* Full lung expansion must be achieved within 12 to 24 hours after drainage
* Expected survival time of at least 2 months
* Subject who score 50 or more on the Karnofsky Performance Scale

Exclusion Criteria

* Subjects with previous attempts at pleurodesis with sclerosing agent
* Subjects with trapped lung or bronchial obstruction
* Subjects with adverse drug response to mistletoe agents
* Subjects who have participated in another clinical study other than the present study
* Subjects who is taking immune-suppressive agents
* Subjects with medical and psychiatric contraindications for the study drug
* Subjects who are not allowed to participate in the study by legal requirement
* Subjects who are not allowed to participate in the study by the Investigator's discretion
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abnoba Gmbh

INDUSTRY

Sponsor Role collaborator

Abnoba Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kook Joo Na, MD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Friedemann Schad, MD

Role: PRINCIPAL_INVESTIGATOR

FORSCHUNGSINSTITUT HAVELHOHE

YongJik Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Ulsan University Hospital

Yeong Dae Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Busan University Hospital

Locations

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Busan University Hospital

Busan, Busan, South Korea

Site Status

Chonnam National University Hwasun hospital

Hwasun Gun, Jeollanam-do, South Korea

Site Status

Ulsan University Hospital

Ulsan, Ulsan, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AB-MPE-2010

Identifier Type: -

Identifier Source: org_study_id

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