Efficacy and Safety Study of Abnoba Viscum F 20mg in Mali... | NCT02191540

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

NCT02191540

Sponsor

Abnoba Korea

Status

Completed

Last Update Posted

Jul 23, 2014Estimated

Enrollment

68Actual

Phase

Phase 3

Conditions

Malignant Pleural Effusion

Interventions

Abnoba Viscum F 20mg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jul 14, 2014

First Submission Date that Met QC Criteria

Jul 14, 2014

First Posted Date

Jul 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2014

Last Update Posted Date

Jul 23, 2014Estimated

Name	Class
Abnoba Gmbh	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abnoba Viscum F 20mg	Experimental		Drug: Abnoba Viscum F 20mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abnoba Viscum F 20mg	Drug	intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space	Abnoba Viscum F 20mg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Busan University Hospital		Busan	Busan	602-739	South Korea
Chonnam National University Hwasun hospital

Condition Browse Module

MeSH Terms

ID	Term
D016066	Pleural Effusion, Malignant

Ancestor Terms

ID	Term
D010997	Pleural Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C077177	viscum album peptide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided