Status:
COMPLETED
Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
Lead Sponsor:
Abnoba Korea
Collaborating Sponsors:
Abnoba Gmbh
Conditions:
Malignant Pleural Effusion
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02191540
Start Date
January 1 2011
End Date
May 1 2013
Last Update
July 23 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Busan University Hospital
Busan, Busan, South Korea, 602-739
2
Chonnam National University Hwasun hospital
Hwasun Gun, Jeollanam-do, South Korea, 519-763
3
Ulsan University Hospital
Ulsan, Ulsan, South Korea, 682-714