Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
A Phase 3, Multi-Center, Single-Arm, Open-Label Study For The Safety And Efficacy Of Mistletoe Extract (AbnobaViscum® Injection) In Malignant Pleural Effusions
1 other identifier
interventional
68
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
3 active sites
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, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedJuly 23, 2014
July 1, 2014
2 years
July 14, 2014
July 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy
Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment
4 weeks
Study Arms (1)
Abnoba Viscum F 20mg
EXPERIMENTALInterventions
intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abnoba Korealead
- Abnoba Gmbhcollaborator
Study Sites (3)
Busan University Hospital
Busan, Busan, 602-739, South Korea
Chonnam National University Hwasun hospital
Hwasun Gun, Jeollanam-do, 519-763, South Korea
Ulsan University Hospital
Ulsan, Ulsan, 682-714, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kook Joo Na, MD
Chonnam National University Hospital
- PRINCIPAL INVESTIGATOR
Friedemann Schad, MD
FORSCHUNGSINSTITUT HAVELHOHE
- PRINCIPAL INVESTIGATOR
YongJik Lee, MD
Ulsan University Hospital
- PRINCIPAL INVESTIGATOR
Yeong Dae Kim, MD
Busan University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2014
First Posted
July 16, 2014
Study Start
January 1, 2011
Primary Completion
January 1, 2013
Study Completion
May 1, 2013
Last Updated
July 23, 2014
Record last verified: 2014-07