Malignant Pleural EffusionPhase 3NCT02191540
Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
A Phase 3 study testing Abnoba Viscum F 20mg in people with Malignant Pleural Effusion, run by Abnoba Korea at 3 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- Abnoba Viscum F 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2011to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Busan University Hospital
Busan, Busan, 602-739
Chonnam National University Hwasun hospital
Hwasun Gun, Jeollanam-do, 519-763
Ulsan University Hospital
Ulsan, Ulsan, 682-714
About this study
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
Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion
- Conditions
- Malignant Pleural Effusion
- Being tested
- Abnoba Viscum F 20mg
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abnoba Viscum F 20mgDrug
Also called viscum album extract, mistletoe extract, abnobaVISCUM
intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space
| Study group | Role | What they receive |
|---|---|---|
| Abnoba Viscum F 20mg | Experimental | Not described Receives: Drug: Abnoba Viscum F 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abnoba Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abnoba Gmbh
- Responsible party
- Sponsor
- Investigators
- Kook Joo Na, MD, Principal investigator, Chonnam National University HospitalFriedemann Schad, MD, Principal investigator, FORSCHUNGSINSTITUT HAVELHOHEYongJik Lee, MD, Principal investigator, Ulsan University HospitalYeong Dae Kim, MD, Principal investigator, Busan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191540
- Sponsor's protocol ID
- AB-MPE-2010
- Status last verified
- Jul 2014
- First submitted
- 14 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02191540
- Acronym / sponsor ID
- AB-MPE-2010
- Conditions
- Malignant Pleural Effusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Abnoba KoreaIndustry (pharma, biotech, devices)
- Collaborators
- Abnoba Gmbh
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abnoba Viscum F 20mg | Experimental | Drug: Abnoba Viscum F 20mg |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abnoba Viscum F 20mgAlso: viscum album extract, mistletoe extract, abnobaVISCUMintravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space | Drug | Abnoba Viscum F 20mg |
Primary outcome
Efficacy
Time frame: 4 weeks
Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kook Joo Na, MD principal investigator
Chonnam National University Hospital
Friedemann Schad, MD principal investigator
FORSCHUNGSINSTITUT HAVELHOHE
YongJik Lee, MD principal investigator
Ulsan University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abnoba Viscum F 20mg in people with Malignant Pleural Effusion, run by Abnoba Korea at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.