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

A Phase 3, Multi-Center, Single-Arm, Open-Label Study For The Safety And Efficacy Of Mistletoe Extract (AbnobaViscum® Injection) In Malignant Pleural Effusions

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001224

Enrollment

Registered

2014-09-15

Start date

2011-05-19

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : * Name of investigational product : Abnoba Viscum F 20mg injection * Dose : 5amples of Abnoba Viscum F 20mg Injection * Number/Period : Determine a dosing interval (approx. 3 to 7 days)accordi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The secondary variables assessed in this study were changes in clinical symptoms (dyspnea, cough, sleep disturbance, pain, appetite)	—

Countries

Korea, Republic of

Contacts

Public Contactinngee Hwang

Abnoba Korea

Outcome results