Acute on Chronic Liver FailureNCT02788240
To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase
A study testing Peg GCSF, 20% Albumin and Nutrition in people with Acute on Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of liver and biliary sciences, irrespective of the etiology , who have survived the acute phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to participate in the study would be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute on Chronic Liver Failure
- What is being tested?
- Peg GCSF, 20% Albumin and Nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2016to 15 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18-65 years
- All patients who were known to have ACLF and have survived 3 months of the onset of acute event
- Patients willing to participate in the study
Who cannot join
- Presence of AKI (Acute Kidney Injury)
- Active sepsis (Blood/ urine culture positive, SBP (Spontaneous bacterial Peritonitis, LRTI (lower Respiratory Tract infection)
- Sickle cell anemia
- HepatoCellular Carcinoma
- Hematological malignancies
- Multi organ failure
Show all 11Show fewer
- Grade 3/ 4 HE (Hepatic Encephalopathy)
- HIV seropositivity
- Pregnancy
- Patients being taken up for transplant
- Refusal to participate in the study
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 Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase - A Randomized Controlled Study
All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of liver and biliary sciences, irrespective of the etiology , who have survived the acute phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to participate in the study would be enrolled. After performing baseline biochemical tests, patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and immunohistochemical examination will be done).
- Conditions
- Acute on Chronic Liver Failure
- Being tested
- Peg GCSF, 20% Albumin, Nutrition, Bowel wash, Terlipressin 1- 4mg,if indicated
- 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.
Peg GCSFDrug
20% AlbuminBiological
NutritionDietary supplement
Bowel washOther
Terlipressin 1- 4mg,if indicatedDrug
Meropenem or Imepenem, if indicatedDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Peg GCSF with standard medical therapy | Experimental | Not described Receives: Drug: Peg GCSF; Biological: 20% Albumin; Dietary Supplement: Nutrition; Other: Bowel wash; Drug: Terlipressin 1- 4mg,if indicated; Drug: Meropenem or Imepenem, if indicated |
| Placebo with standard medical therapy | Active comparator | Not described Receives: Biological: 20% Albumin; Dietary Supplement: Nutrition; Other: Bowel wash; Drug: Terlipressin 1- 4mg,if indicated; Drug: Meropenem or Imepenem, if indicated; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival in both groups
Measured: 1 year
Secondary outcomes (13)
Quantitative assessment of CD34 positive cells in serum in both groups.
On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done
Measured: 1 year
Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups.
On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done
Measured: 1 year
Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups.
Measured: 1 year
Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups.
Measured: 1 year
Development of new onset complications such as hepatic encephalopathy in both groups.
Measured: 1 year
Development of new onset complications such as hepatorenal syndrome in both groups.
Measured: 1 year
Development of new onset complications such as sepsis in both groups.
Measured: 1 year
Development of new onset complications such as Hepatocellular carcinoma (HCC).
Measured: 1 year
Total number of CD34 positive cells in histopathological examination of bone marrow in both groups
Measured: 1 year
No of adverse events in both groups
Measured: 1 year
Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups
Measured: 1 year
Reduction in HBV DNA level in both groups.
Measured: 1 year
Number of patients who will restart alcohol abuse during the follow up period in both groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start1 May 2016
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 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
- NCT02788240
- Sponsor's protocol ID
- ILBS-ACLF-008
- Status last verified
- Feb 2018
- First submitted
- 22 Mar 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02788240
- Acronym / sponsor ID
- ILBS-ACLF-008
- Conditions
- Acute on Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 2 Jun 2016 (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.
All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of liver and biliary sciences, irrespective of the etiology , who have survived the acute phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to participate in the study would be enrolled. After performing baseline biochemical tests, patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and immunohistochemical examination will be done).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peg GCSF with standard medical therapy | Experimental | Drug: Peg GCSF, Biological: 20% Albumin, Dietary Supplement: Nutrition, Other: Bowel wash, Drug: Terlipressin 1- 4mg,if indicated, Drug: Meropenem or Imepenem, if indicated |
| Placebo with standard medical therapy | Active comparator | Biological: 20% Albumin, Dietary Supplement: Nutrition, Other: Bowel wash, Drug: Terlipressin 1- 4mg,if indicated, Drug: Meropenem or Imepenem, if indicated, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 18-65 years
- All patients who were known to have ACLF and have survived 3 months of the onset of acute event
- Patients willing to participate in the study
Key exclusion criteria (11 listed)
- Presence of AKI (Acute Kidney Injury)
- Active sepsis (Blood/ urine culture positive, SBP (Spontaneous bacterial Peritonitis, LRTI (lower Respiratory Tract infection)
- Sickle cell anemia
- HepatoCellular Carcinoma
- Hematological malignancies
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 |
|---|---|---|
| Peg GCSF | Drug | Peg GCSF with standard medical therapy |
| 20% Albumin | Biological | Peg GCSF with standard medical therapy, Placebo with standard medical therapy |
| Nutrition | Dietary supplement | Peg GCSF with standard medical therapy, Placebo with standard medical therapy |
| Bowel wash | Other | Peg GCSF with standard medical therapy, Placebo with standard medical therapy |
| Terlipressin 1- 4mg,if indicated | Drug | Peg GCSF with standard medical therapy, Placebo with standard medical therapy |
| Meropenem or Imepenem, if indicated | Drug | Peg GCSF with standard medical therapy, Placebo with standard medical therapy |
| Placebo | Drug | Placebo with standard medical therapy |
Primary outcome
Transplant free survival in both groups
Time frame: 1 year
13 secondary outcomes
Quantitative assessment of CD34 positive cells in serum in both groups.
Time frame: 1 year
Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups.
Time frame: 1 year
Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups.
Time frame: 1 year
Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups.
Time frame: 1 year
Development of new onset complications such as hepatic encephalopathy in both groups.
Time frame: 1 year
Development of new onset complications such as hepatorenal syndrome in both groups.
Time frame: 1 year
Development of new onset complications such as sepsis in both groups.
Time frame: 1 year
Development of new onset complications such as Hepatocellular carcinoma (HCC).
Time frame: 1 year
Total number of CD34 positive cells in histopathological examination of bone marrow in both groups
Time frame: 1 year
No of adverse events in both groups
Time frame: 1 year
Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups
Time frame: 1 year
Reduction in HBV DNA level in both groups.
Time frame: 1 year
Number of patients who will restart alcohol abuse during the follow up period in both groups.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Acute on Chronic Liver Failure
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Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
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
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
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 Peg GCSF, 20% Albumin and Nutrition 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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 Feb 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 stopped early. Results are not available in the source record.
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 in both groups (time frame: 1 year). 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 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.