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

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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

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

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Drug: Abnoba Viscum F 20mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013

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




Primary Outcome Measures :
  1. Efficacy [ Time Frame: 4 weeks ]
    Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191540


Locations
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Korea, Republic of
Chonnam National University Hwasun hospital
Hwasun gun, Jeolla Namdo, Korea, Republic of, 519-763
Busan University Hospital
Busan, Korea, Republic of, 602-739
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Abnoba Korea
Abnoba Gmbh
Investigators
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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

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Responsible Party: Abnoba Korea
ClinicalTrials.gov Identifier: NCT02191540     History of Changes
Other Study ID Numbers: AB-MPE-2010
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Viscum album peptide
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents