Portal Vein ThrombosisPhase 3NCT02250391
Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis
A Phase 3 study testing NPB-06 in people with Portal Vein Thrombosis, run by Nihon Pharmaceutical Co., Ltd at 5 sites in Japan.
Trial summary
Patients with portal vein thrombosis, who have chronic liver diseases especially liver cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06 or placebo. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- NPB-06
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 5 sitesJapan
- Study dates
- Sep 2014to Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients or outpatients meet the criteria (1)-(4) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.
- Patients who the serum level of AT-III is 70% or less
- Patients with portal vein thrombosis detected by ultrasonography
- Patients who have more than 50% of the thrombus lumen occupancy
- Patients who are older than 20 years at the time of consent
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study beforehand.
- Patients with tumor embolus in portal vein
- Patients with an ongoing hepatic intra-arterial chemotherapy such as implantable reservoir system
- Patients with hepatocellular cancer of more than 3 cm in diameter or more than four hepatocellular cancers
- Patients with residual or chronic portal vein thrombosis
- Patients with advanced liver disease (Child-Pugh score 11 or more)
Show all 18Show fewer
- Patients with bleeding tendency
- Patients who had an anticoagulation therapy (intravenous or subcutaneous dose) or hemostasis with an enzymatic hemostatic agent in the period between 7 days before contrast enhanced CT of pre-dose and the day acquired written informed consent
- Patients who had an anticoagulation therapy (oral dose) in the period between 7 days before contrast enhanced CT of pre-dose and the day acquired written informed consent
- Patients with a history of shock or hypersensitivity to NPB-06
- Patients with inappropriate to contrast agents
- A history of allergy of iodine or X-ray contrast agent
- Complication of serious thyroid disease
- Reduced renal function
- Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
- Patients who have received NPB-06
- Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
- Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Chūbu
Study site
Hokkaido
Study site
Kanto
Study site
Kyushu
Study site
Osaka
About this study
Patients with portal vein thrombosis, who have chronic liver diseases especially liver cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06 or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis.
The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and 21 days after administration in comparison with the placebo group.
- Conditions
- Portal Vein Thrombosis
- Being tested
- NPB-06, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPB-06Drug
5 days continuous-infusion
PlaceboDrug
5 days continuous-infusion
| Study group | Role | What they receive |
|---|---|---|
| NPB-06 | Experimental | 1,500 unit, 5 days continuous-infusion Receives: Drug: NPB-06 |
| Placebo | Placebo comparator | 0 unit, 5 days continuous-infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis
Contrast enhanced CT assessed by an independent radiologist
Measured: an expected average of 2 weeks
Secondary outcomes (5)
The proportion of patients obtained complete recanalization of portal vein thrombosis
Measured: an expected average of 2 weeks
Reduction rate of portal vein thrombosis
Measured: Up to 3 weeks
Improvement of Child-Pugh score
Measured: Up to 5 weeks
Changes in laboratory values (congealing fibrinogenolysis system)
Measured: Up to 5 weeks
Adverse events and adverse drug reactions observed between administration and 21 ± 3 days after administration
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250391
- Sponsor's protocol ID
- NPB-06-04/C-01
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2014
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis
- ClinicalTrials.gov ID
- NCT02250391
- Acronym / sponsor ID
- NPB-06-04/C-01
- Conditions
- Portal Vein Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Sep 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.
Patients with portal vein thrombosis, who have chronic liver diseases especially liver cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06 or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis.
The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and 21 days after administration in comparison with the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPB-06 | Experimental | Drug: NPB-061,500 unit, 5 days continuous-infusion |
| Placebo | Placebo comparator | Drug: Placebo0 unit, 5 days continuous-infusion |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatients or outpatients meet the criteria (1)-(4) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.
- Patients who the serum level of AT-III is 70% or less
- Patients with portal vein thrombosis detected by ultrasonography
- Patients who have more than 50% of the thrombus lumen occupancy
- Patients who are older than 20 years at the time of consent
Key exclusion criteria (18 listed)
- Patients who meet any of the following criteria will be excluded from the study beforehand.
- Patients with tumor embolus in portal vein
- Patients with an ongoing hepatic intra-arterial chemotherapy such as implantable reservoir system
- Patients with hepatocellular cancer of more than 3 cm in diameter or more than four hepatocellular cancers
- Patients with residual or chronic portal vein thrombosis
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 |
|---|---|---|
| NPB-065 days continuous-infusion | Drug | NPB-06 |
| Placebo5 days continuous-infusion | Drug | Placebo |
Primary outcome
The proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis
Time frame: an expected average of 2 weeks
Contrast enhanced CT assessed by an independent radiologist
5 secondary outcomes
The proportion of patients obtained complete recanalization of portal vein thrombosis
Time frame: an expected average of 2 weeks
Reduction rate of portal vein thrombosis
Time frame: Up to 3 weeks
Improvement of Child-Pugh score
Time frame: Up to 5 weeks
Changes in laboratory values (congealing fibrinogenolysis system)
Time frame: Up to 5 weeks
Adverse events and adverse drug reactions observed between administration and 21 ± 3 days after administration
Time frame: Up to 5 weeks
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 9 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 NPB-06 in people with Portal Vein Thrombosis, run by Nihon Pharmaceutical Co., Ltd at 5 sites in Japan.
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 5 inclusion and 18 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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. Some participants in this study may receive a placebo. 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?
The proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis (time frame: an expected average of 2 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 9 Sep 2016.