Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
Primary Purpose
Malignant Pleural Effusion
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Abnoba Viscum F 20mg
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Pleural Effusion
Eligibility Criteria
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
Sites / Locations
- Chonnam National University Hwasun hospital
- Busan University Hospital
- Ulsan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abnoba Viscum F 20mg
Arm Description
Outcomes
Primary Outcome Measures
Efficacy
Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT02191540
First Posted
July 14, 2014
Last Updated
July 21, 2014
Sponsor
Abnoba Korea
Collaborators
Abnoba Gmbh
1. Study Identification
Unique Protocol Identification Number
NCT02191540
Brief Title
Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
Official Title
A Phase 3, Multi-Center, Single-Arm, Open-Label Study For The Safety And Efficacy Of Mistletoe Extract (AbnobaViscum® Injection) In Malignant Pleural Effusions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abnoba Korea
Collaborators
Abnoba Gmbh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abnoba Viscum F 20mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Abnoba Viscum F 20mg
Other Intervention Name(s)
viscum album extract, mistletoe extract, abnobaVISCUM
Intervention Description
intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space
Primary Outcome Measure Information:
Title
Efficacy
Description
Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kook Joo Na, MD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Friedemann Schad, MD
Organizational Affiliation
FORSCHUNGSINSTITUT HAVELHOHE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YongJik Lee, MD
Organizational Affiliation
Ulsan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yeong Dae Kim, MD
Organizational Affiliation
Busan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun hospital
City
Hwasun gun
State/Province
Jeolla Namdo
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Busan University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
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