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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02191540
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
Abnoba Gmbh
Information provided by (Responsible Party):
Abnoba Korea

Tracking Information
First Submitted Date  ICMJE July 14, 2014
First Posted Date  ICMJE July 16, 2014
Last Update Posted Date July 23, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
Efficacy [ Time Frame: 4 weeks ]
Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02191540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
Official Title  ICMJE A Phase 3, Multi-Center, Single-Arm, Open-Label Study For The Safety And Efficacy Of Mistletoe Extract (AbnobaViscum® Injection) In Malignant Pleural Effusions
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Effusion
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Abnoba Viscum F 20mg
Intervention: Drug: Abnoba Viscum F 20mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2014)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02191540
Other Study ID Numbers  ICMJE AB-MPE-2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abnoba Korea
Study Sponsor  ICMJE Abnoba Korea
Collaborators  ICMJE Abnoba Gmbh
Investigators  ICMJE
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
PRS Account Abnoba Korea
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP