Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abnoba Korea
• Collaborator: Abnoba Gmbh
• Treatments: Viscum album peptide

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