Acute-On-Chronic Liver FailureNCT03162419
To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF).
A study testing Standard Medical Therapy, Plasma Exchange and GCSF in people with Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Study design-Open label randomized controlled trial Study period-2 years Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb 2017 to Dec 2018 All the patients of ACLF will receive standard medical therapy and will be randomized within 48 hours of admission into three groups after… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- Standard Medical Therapy, Plasma Exchange and GCSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2017to 25 Apr 2019
- 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
- All consecutive patients in age group of 18-70 years with acute on chronic liver failure as defined by APASL criteria shall be included in the study.Only those patients who wish to be enrolled in the trial shall be included in the study.
Who cannot join
- Steroid eligible patients with severe alcoholic hepatitis
- Cirrhosis of liver with previous history of decompensation
- Patients with severe cardiopulmonary disease
- Pregnancy
- Human Immmunodeficiency Virus infection
- Hepatocellular carcinoma or extrahepatic malignancy
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- Chronic renal insufficiency on treatment with haemodialysis
- Uncontrolled bleed or patients in disseminated intravascular coagulopathy
- Patient with expected survival of less than 48 hours
- Patients with moderate-severe acute respiratory distress syndrome
- Hemodynamic instability with noradrenaline requirement of more than >0.5ug/kg/min or requirement of dual vasopressors
- Patients with leukemoid reaction or total leucocyte count > 40,000/mm3
- Patients diagnosed with Hemophagocytic Lymphohistiocytosis
- Patients with known hypersensitivity to Granulocyte colony stimulating factor
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
Official title: To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF)-A Randomized Controlled Trial.
Study design-Open label randomized controlled trial
Study period-2 years
Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb 2017 to Dec 2018
All the patients of ACLF will receive standard medical therapy and will be randomized within 48 hours of admission into three groups after screening for exclusion and inclusion criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy + Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- Standard Medical Therapy, Plasma Exchange, GCSF
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical TherapyDrug
The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
Plasma ExchangeBiological
High volume plasma exchange sessions till a maximum of ten sessions.
GCSFBiological
The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Therapy | Active comparator | The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. Receives: Drug: Standard Medical Therapy |
| Standard Medical Therapy + Plasma exchange + GCSF | Experimental | The patients in group B shall be given GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 along with alternate day high volume plasma exchange sessions till a maximum of ten sessions. Receives: Drug: Standard Medical Therapy; Biological: Plasma Exchange; Biological: GCSF |
| Standard Medical Therapy + GCSF | Experimental | The patients in this will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 Receives: Drug: Standard Medical Therapy; Biological: GCSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival
Measured: 28 days
Secondary outcomes (10)
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Measured: Day 14
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Measured: Day 28
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Measured: Day 14
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Measured: Day 28
Improvement in APACHEII (by 2 points )
Measured: 2 years
Improvement in MELD (by 2 points )
Measured: 2 years
Improvement in SIRS by 2 points
Measured: 2 years
Improvement in SOFA (by 2 points )
Measured: 2 years
Incidence of new onset sepsis and SIRS in both groups.
Measured: Day 28
Side effects of therapy 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 posted22 May 2017
- Study start1 May 2017
- Primary completion25 Apr 2019 (estimated)
- Study completion25 Apr 2019 (estimated)
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 Acute-On-Chronic Liver FailureStudies 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
- None (open label)
- 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
- NCT03162419
- Sponsor's protocol ID
- ILBS-ACLF-01
- Status last verified
- Jun 2018
- First submitted
- 20 Apr 2017
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF)-A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03162419
- Acronym / sponsor ID
- ILBS-ACLF-01
- Conditions
- Acute-On-Chronic Liver Failure
- 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
- 1 May 2017 (actual)
- Primary completion
- 25 Apr 2019 (estimated)
- Study completion
- 25 Apr 2019 (estimated)
- First posted
- 22 May 2017 (actual)
- 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.
Study design-Open label randomized controlled trial
Study period-2 years
Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb 2017 to Dec 2018
All the patients of ACLF will receive standard medical therapy and will be randomized within 48 hours of admission into three groups after screening for exclusion and inclusion criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy + Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Therapy | Active comparator | Drug: Standard Medical TherapyThe patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. |
| Standard Medical Therapy + Plasma exchange + GCSF | Experimental | Drug: Standard Medical Therapy, Biological: Plasma Exchange, Biological: GCSFThe patients in group B shall be given GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 along with alternate day high volume plasma exchange sessions till a maximum of ten sessions. |
| Standard Medical Therapy + GCSF | Experimental | Drug: Standard Medical Therapy, Biological: GCSFThe patients in this will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients in age group of 18-70 years with acute on chronic liver failure as defined by APASL criteria shall be included in the study.Only those patients who wish to be enrolled in the trial shall be included in the study.
Key exclusion criteria (14 listed)
- Steroid eligible patients with severe alcoholic hepatitis
- Cirrhosis of liver with previous history of decompensation
- Patients with severe cardiopulmonary disease
- Pregnancy
- Human Immmunodeficiency Virus infection
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 |
|---|---|---|
| Standard Medical TherapyThe patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. | Drug | Standard Medical Therapy, Standard Medical Therapy + GCSF, Standard Medical Therapy + Plasma exchange + GCSF |
| Plasma ExchangeHigh volume plasma exchange sessions till a maximum of ten sessions. | Biological | Standard Medical Therapy + Plasma exchange + GCSF |
| GCSFThe GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 | Biological | Standard Medical Therapy + GCSF, Standard Medical Therapy + Plasma exchange + GCSF |
Primary outcome
Transplant free survival
Time frame: 28 days
10 secondary outcomes
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Time frame: Day 14
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups
Time frame: Day 28
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Time frame: Day 14
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups
Time frame: Day 28
Improvement in APACHEII (by 2 points )
Time frame: 2 years
Improvement in MELD (by 2 points )
Time frame: 2 years
Improvement in SIRS by 2 points
Time frame: 2 years
Improvement in SOFA (by 2 points )
Time frame: 2 years
Incidence of new onset sepsis and SIRS in both groups.
Time frame: Day 28
Side effects of therapy 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 3 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Acute-On-Chronic Liver Failure
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
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Very Low-volume Plasma Exchange in ACLF
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Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
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 Standard Medical Therapy, Plasma Exchange and GCSF in people with Acute-On-Chronic Liver Failure, 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 1 inclusion and 14 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 3 Dec 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. 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?
Transplant free survival (time frame: 28 days). 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 3 Dec 2018.