Malignant Pleural Effusion
Conditions
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
Interventions
DRUGAbnoba Viscum F 20mg
intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space
Sponsors
Abnoba Gmbh
Abnoba Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 4 weeks | Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment |
Countries
South Korea
Outcome results
None listed