Trial | NCT02191540  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mistletoe ...

  • Study Participants

    68
Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion
Study Started
Jan 31
2011
Primary Completion
Jan 31
2013
Study Completion
May 31
2013
Last Update
Jul 23
2014
Estimate

Drug Abnoba Viscum F 20mg

intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space

  • Other names: viscum album extract, mistletoe extract, abnobaVISCUM

Abnoba Viscum F 20mg Experimental

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
No Results Posted