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

Malignant Pleural Effusion Clinical Trial

Official title:

A Phase 3, Multi-Center, Single-Arm, Open-Label Study For The Safety And Efficacy Of Mistletoe Extract (AbnobaViscum® Injection) In Malignant Pleural Effusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191540
• Other study ID #: AB-MPE-2010
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2014
• Last updated: July 21, 2014
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: Abnoba Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• Abnoba Viscum F 20mg
intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space

Locations

Country	Name	City	State
Korea, Republic of	Busan University Hospital	Busan
Korea, Republic of	Chonnam National University Hwasun hospital	Hwasun gun	Jeolla Namdo
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Abnoba Korea	Abnoba Gmbh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment	4 weeks	No