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

Study Overview

• Status: Completed
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Drug: Abnoba Viscum F 20mg

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Busan University Hospital
  • Ulsan, Korea, Republic of, 682-714
    • Ulsan University Hospital
  • Jeolla Namdo
    • Hwasun gun, Jeolla Namdo, Korea, Republic of, 519-763
      • Chonnam National University Hwasun Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abnoba Viscum F 20mg	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment	4 weeks

Collaborators and Investigators

• Sponsor: Abnoba Korea
• Collaborators: Abnoba Gmbh
• Investigators: Principal Investigator: Kook Joo Na, MD, Chonnam National University Hospital; Principal Investigator: Friedemann Schad, MD, FORSCHUNGSINSTITUT HAVELHOHE; Principal Investigator: YongJik Lee, MD, Ulsan University Hospital; Principal Investigator: Yeong Dae Kim, MD, Busan University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 21, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: AB-MPE-2010