Portal Vein ThrombosisNCT01631877
Efficacy and Safety of Acenocoumarol for Treatment of Nontumor Portal Vein Thrombosis in Cirrhosis of Liver
A study testing Enoxaparin with acenocoumarol in people with Portal Vein Thrombosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (acenocoumarol) or placebo group along with first five days… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- Enoxaparin with acenocoumarol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2012to 1 Jun 2017
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical, radiological or histologic diagnosis of cirrhosis
- Partial or total Portal vein thrombus (evidence of chronic thrombus)
- Informed consent to participate in the study
Who cannot join
- Acute thrombus in Portal vein
- Hepatocellular carcinoma or any other malignancy,
- Hypercoagulable state other than the liver disease related
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- Base line INR >2
- Child Turcott Pugh score>11
Show all 12Show fewer
- Recent peptic ulcer disease
- History of Hemorrhagic stroke
- Pregnancy.
- Uncontrolled Hypertension
- Age>70 yrs
- Non responders to beta-blocker requiring Endoscopic Variceal Ligation
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences.
New Delhi, National Capital Territory of Delhi, 110070
About this study
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (acenocoumarol) or placebo group along with first five days of subcutaneous Low Molecular Weight Heparin inj. Enoxaparin in the interventional arm and placebo injection in the control arm. Every 3 monthly the Doppler screening for recanalization of portal vein thrombus will be done with monitoring of International Normalized Ratio (INR)with target INR 2-3. Both the groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus re-canalization.Then one year drug free monitoring will be done in both the groups as per the primary or secondary outcome. .
- Conditions
- Portal Vein Thrombosis
- Being tested
- Enoxaparin with acenocoumarol, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin with acenocoumarolDrug
enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg to start with and dose to be adjusted for the target INR
placeboOther
injection placebo will be given for 5 days along with placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| enoxaparin with acenocoumarol | Experimental | Patients will receive enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg with titration of dose to maintain a target INR of 2-3.intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR.After achieving the target INR this is to be repeated every 4th weekly. The Doppler Ultra Sonography screening will be done every 3monthly to assess the recanalization of portal vein thrombus but the medications will be continue for one year irrespective of recanalization. Receives: Drug: Enoxaparin with acenocoumarol |
| Placebo | Placebo comparator | Injection placebo will be given for 5 days along with placebo tablets. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of patients who will achieve Recanalization of thrombus (complete i.e No thrombus is seen or partial i.e up to 50% of the lumen become patent.)on oral anticoagulant acenocoumarol during the study period of 2 year from randomization.
Measured: 2 years
Secondary outcomes (4)
Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups
Measured: 2 years
Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups
Measured: 2 years
Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups
Measured: 2 years
Proportions of patients will show decrease in hepatic decompensation i.e hepatic encephalopathy,ascites,hepato renal syndrome,variceal bleed,jaundice and coagulopathy in both groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJun 2012
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Why it stopped: lack of funds
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.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631877
- Sponsor's protocol ID
- ILBS- PVT-01
- Status last verified
- Dec 2016
- First submitted
- 15 Jun 2012
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acenocoumarol for Treatment of Nontumor Portal Vein Thrombosis in Cirrhosis of Liver
- ClinicalTrials.gov ID
- NCT01631877
- Acronym / sponsor ID
- ILBS- PVT-01
- Conditions
- Portal Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 29 Jun 2012 (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.
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (acenocoumarol) or placebo group along with first five days of subcutaneous Low Molecular Weight Heparin inj. Enoxaparin in the interventional arm and placebo injection in the control arm. Every 3 monthly the Doppler screening for recanalization of portal vein thrombus will be done with monitoring of International Normalized Ratio (INR)with target INR 2-3. Both the groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus re-canalization.Then one year drug free monitoring will be done in both the groups as per the primary or secondary outcome. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enoxaparin with acenocoumarol | Experimental | Drug: Enoxaparin with acenocoumarolPatients will receive enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg with titration of dose to maintain a target INR of 2-3.intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR.After achieving the target INR this is to be repeated every 4th weekly. The Doppler Ultra Sonography screening will be done every 3monthly to assess the recanalization of portal vein thrombus but the medications will be continue for one year irrespective of recanalization. |
| Placebo | Placebo comparator | Other: placeboInjection placebo will be given for 5 days along with placebo tablets. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A clinical, radiological or histologic diagnosis of cirrhosis
- Partial or total Portal vein thrombus (evidence of chronic thrombus)
- Informed consent to participate in the study
Key exclusion criteria (12 listed)
- Acute thrombus in Portal vein
- Hepatocellular carcinoma or any other malignancy,
- Hypercoagulable state other than the liver disease related
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- Base line INR >2
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 |
|---|---|---|
| Enoxaparin with acenocoumarolenoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg to start with and dose to be adjusted for the target INR | Drug | enoxaparin with acenocoumarol |
| placeboinjection placebo will be given for 5 days along with placebo tablets | Other | Placebo |
Primary outcome
Proportions of patients who will achieve Recanalization of thrombus (complete i.e No thrombus is seen or partial i.e up to 50% of the lumen become patent.)on oral anticoagulant acenocoumarol during the study period of 2 year from randomization.
Time frame: 2 years
4 secondary outcomes
Proportions of patients who will show improvement in Child Turcott Pugh (CTP) (>2 points)in both groups
Time frame: 2 years
Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups
Time frame: 2 years
Proportions of patients who will achieve reduction in liver stiffness > 5 Kpa by transient elastography in both groups
Time frame: 2 years
Proportions of patients will show decrease in hepatic decompensation i.e hepatic encephalopathy,ascites,hepato renal syndrome,variceal bleed,jaundice and coagulopathy in both groups.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparin with acenocoumarol in people with Portal Vein Thrombosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportions of patients who will achieve Recanalization of thrombus (complete i.e No thrombus is seen or partial i.e up to 50% of the lumen become patent.)on oral anticoagulant acenocoumarol during the study period of 2 year from randomization. (time frame: 2 years). 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 6 Jun 2018.