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

Not Applicable

Completed

Conditions: Diseases of th respiratory system

Registration Number: KCT0001224

Lead Sponsor: Abnoba Korea

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 68

Inclusion Criteria

1. Signed informed consent
a. Subjects must have voluntarily signed and dated an IRB/IEC approved written
informed consent form in accordance with regulatory and institutional
guidelines, This must be obtained before the performance of any protocol
related procedures that are not part of normal subject care.
2. Target population
a. Subjects who need the pleurodesis among subjects diagnosed with a malignant
pleural effusion
b. Full lung expansion must be achieved within 12 to 24 hours after drainage.
c. Expected survival time of at least 2 months
d. Subjects who score 50 or more on the Karnofshy perfomance Scale.

Exclusion Criteria

1. Subjects with previous attempts at pleurodesis with sclerosing agent
2. Subjects with trapped lung or bronchial obstruction
3. Subjects with adverse drug reponses to mistletoe agents
4. Subjects who have participated in another clinical study other than the
present study.
5. Subjects who is taking immune-suppressive agents
6. Subjects with medical and psychiatric contraindications for the study drug
7. Subjects who are not allowed to participate in the study by legal requirements
8. Subjects who are not allowed to participate in the study by the investigator's
discretion.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy variables assessed in this study were the reponse rate (complete respose (CR) and partial response (PR)) in pleural effusions by a simple x-ray examination;The safety variables assessed were adverse events newly occurred after injecting the study drug and the results of vital signs, physical examinations and clinical laboratory tests performed

Secondary Outcome Measures