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Completed

NCT Number: NCT02191540

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

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

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Key information

Conditions

Malignant Pleural Effusion Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Busan University Hospital, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abnoba Viscum F 20mg

Drug

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 outcomes

  1. Efficacy

    Time frame: 4 weeks

    Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment

Sponsors and collaborators

Lead sponsor

Abnoba Korea

Industry

Collaborators

  • Abnoba Gmbh

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 16, 2014
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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