Liver CirrhosisNCT04058613
Effects of Maintaining Steady Albumin Levels (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites
A study testing ALB Protein, Human in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 4.0 g/dl in newly detected cirrhotic patients with low albumin levels (<2.8g/dl) with ascites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- ALB Protein, Human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteIndia
- Study dates
- 10 Sep 2019to 8 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly detected cirrhotic patients aged more than 18 years
- Cirrhosis defined by standard clinical, analytical and/or histological criteria
- Serum albumin level < 2.8g/dl with or without ascites
- Who would agree to give written informed consent
Who cannot join
- Uncontrolled HTN (sys>150/ dis >90 mmHg) or h/o any drug therapy for HTN
- Prior h/o Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Hepatocellular Carcinoma
- Active alcohol abuse within 3 months
- Patients presenting as Acute on Chronic Liver Failure
- Extrahepatic organ failure
Show all 15Show fewer
- Known case of chronic heart failure or respiratory failure
- Diagnosed Chronic Kidney Disease
- Patients with hydrothorax
- Prior liver transplant recipient
- Human Immunodeficiency Virus infection
- Use of albumin infusion in the last one month
- CTP>12, MELD>28
- Total Bilirubin >3 g/dl
- Overt Hepatic Encephalopathy at Presentation
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Shasthry SM, MD, 01146300000, shasthry@gmail.com
About this study
Official title: Effects of Maintaining Steady Albumin Levels by Targeted Albumin Therapy (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites and Low Serum Albumin Level- a Randomized Controlled Trial
Investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 4.0 g/dl in newly detected cirrhotic patients with low albumin levels (<2.8g/dl) with ascites.
Read the detailed description
Cirrhosis is characterized by progressive deterioration in liver functions. Liver's synthetic functions are inferred by serum albumin and INR estimation. Lower albumin level is a marker of severe liver disease and probability of worsening ascites, hepatorenal syndrome with increased risk for infections. Of the three recent RCTs on utility of long-term administration of albumin, two showed improvement in survival. The studies had included different patient populations (diuretic refractory ascites, high dose diuretics and patients on liver transplant waiting list) with different albumin infusion protocols and different end-points. These studies were done in advanced cases of cirrhosis. There is limited data on the utility of regular albumin infusions in early hepatic decompensation (albumin levels-<2.8g/dl with ascites) and the effect of maintaining a targeted albumin level on survival or liver related side effects. Investigators are trying to address this issue by starting regular albumin infusions at an earlier stage of liver decompensation.
- Conditions
- Liver Cirrhosis
- Being tested
- ALB Protein, Human, placebo
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALB Protein, HumanDrug
Albumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Experimental | Albumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy Receives: Drug: ALB Protein, Human |
| Placebo | Placebo comparator | Placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant/Transintrahepatic Portosystemic Shunt (TIPS) free survival in both groups
1 year survival
Measured: 12 months
Secondary outcomes (11)
New onset refractory ascites in both the groups
refractory ascites is defined as non response to maximum tolerated dose of diuretics
Measured: 12 months
Spontaneous bacterial peritonitis [SBP] in both groups
Spontaneous bacterial peritonitis is defined as ascitic fluid absolute neutrophil count > 250/ mL with or without culture positivity
Measured: 12 months
Renal impairment in both groups
serum creatinine concentration >1•5 mg/dL
Measured: 12 months
Hepatorenal Syndrome in both groups
Hepatorenal Syndrome type 1 is defined as new onset increase in serum creatinine level by 0.3 mg/dL or 50% increase from baseline
Measured: 12 months
Hepatic encephalopathy grade 3 or 4 in both groups
HE as per West Haven criteria
Measured: 12 months
Number of new cases with gastrointestinal bleeding in both groups
gastrointestinal bleeding as confirmed by endoscopic/clinical evidence of variceal bleed.
Measured: 12 months
Requirement of paracentesis in both groups
Ascitic tapping for relieve of pressure symptoms or diagnosis of SBP
Measured: 12 months
Requirement of diuretics in both groups
Frusemide or Aldactone for management of ascites
Measured: 12 months
Number of hospitalizations per subject in both groups
Need for any cause hospitalization
Measured: 12 months
New onset breathlessness/ Hypertension within 24 hours of albumin infusion in both groups
Development of cardiac overload
Measured: within 24 hours
Quality of life by Ascite-Q questionnaire in both groups
semiquantitative questionnaire to be answered by the participants
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start10 Sep 2019 (estimated)
- Primary completion8 Aug 2020 (estimated)
- Study completion8 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shasthry SM, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058613
- Sponsor's protocol ID
- ILBS-TAT4-01
- Status last verified
- Sep 2019
- First submitted
- 13 Aug 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maintaining Steady Albumin Levels by Targeted Albumin Therapy (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites and Low Serum Albumin Level- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04058613
- Acronym / sponsor ID
- ILBS-TAT4-01
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 10 Sep 2019 (estimated)
- Primary completion
- 8 Aug 2020 (estimated)
- Study completion
- 8 Aug 2021 (estimated)
- First posted
- 15 Aug 2019 (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.
Investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 4.0 g/dl in newly detected cirrhotic patients with low albumin levels (<2.8g/dl) with ascites.
Detailed description
Cirrhosis is characterized by progressive deterioration in liver functions. Liver's synthetic functions are inferred by serum albumin and INR estimation. Lower albumin level is a marker of severe liver disease and probability of worsening ascites, hepatorenal syndrome with increased risk for infections. Of the three recent RCTs on utility of long-term administration of albumin, two showed improvement in survival. The studies had included different patient populations (diuretic refractory ascites, high dose diuretics and patients on liver transplant waiting list) with different albumin infusion protocols and different end-points. These studies were done in advanced cases of cirrhosis. There is limited data on the utility of regular albumin infusions in early hepatic decompensation (albumin levels-<2.8g/dl with ascites) and the effect of maintaining a targeted albumin level on survival or liver related side effects. Investigators are trying to address this issue by starting regular albumin infusions at an earlier stage of liver decompensation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin | Experimental | Drug: ALB Protein, HumanAlbumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy |
| Placebo | Placebo comparator | Other: placeboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly detected cirrhotic patients aged more than 18 years
- Cirrhosis defined by standard clinical, analytical and/or histological criteria
- Serum albumin level < 2.8g/dl with or without ascites
- Who would agree to give written informed consent
Key exclusion criteria (15 listed)
- Uncontrolled HTN (sys>150/ dis >90 mmHg) or h/o any drug therapy for HTN
- Prior h/o Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Hepatocellular Carcinoma
- Active alcohol abuse within 3 months
- Patients presenting as Acute on Chronic Liver Failure
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 |
|---|---|---|
| ALB Protein, HumanAlbumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy | Drug | Albumin |
| placeboplacebo | Other | Placebo |
Primary outcome
Transplant/Transintrahepatic Portosystemic Shunt (TIPS) free survival in both groups
Time frame: 12 months
1 year survival
11 secondary outcomes
New onset refractory ascites in both the groups
Time frame: 12 months
Spontaneous bacterial peritonitis [SBP] in both groups
Time frame: 12 months
Renal impairment in both groups
Time frame: 12 months
Hepatorenal Syndrome in both groups
Time frame: 12 months
Hepatic encephalopathy grade 3 or 4 in both groups
Time frame: 12 months
Number of new cases with gastrointestinal bleeding in both groups
Time frame: 12 months
Requirement of paracentesis in both groups
Time frame: 12 months
Requirement of diuretics in both groups
Time frame: 12 months
Number of hospitalizations per subject in both groups
Time frame: 12 months
New onset breathlessness/ Hypertension within 24 hours of albumin infusion in both groups
Time frame: within 24 hours
Quality of life by Ascite-Q questionnaire in both groups
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALB Protein, Human in people with Liver Cirrhosis, 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 12 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Shasthry SM, MD (01146300000, shasthry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant/Transintrahepatic Portosystemic Shunt (TIPS) free survival in both groups (time frame: 12 months). 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 12 Sep 2019.