Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
NCT ID: NCT02191540
Last Updated: 2014-07-23
Study Results
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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COMPLETED
PHASE3
68 participants
INTERVENTIONAL
2011-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abnoba Viscum F 20mg
Abnoba Viscum F 20mg
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
80 Years
ALL
No
Sponsors
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Abnoba Gmbh
INDUSTRY
Abnoba Korea
INDUSTRY
Responsible Party
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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
Chonnam National University Hwasun hospital
Hwasun Gun, Jeollanam-do, South Korea
Ulsan University Hospital
Ulsan, Ulsan, South Korea
Countries
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Other Identifiers
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AB-MPE-2010
Identifier Type: -
Identifier Source: org_study_id
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