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

Abnoba

Status and phase: Completed; Phase 3

Conditions: Malignant Pleural Effusion

Treatments: Drug: Abnoba Viscum F 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02191540

AB-MPE-2010

Details and patient eligibility

About

Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion

Enrollment: 68 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Abnoba Viscum F 20mg

Experimental group

Treatment:

Drug: Abnoba Viscum F 20mg