A Phase 2/3 interventional study of Terlipressin Injectable Product in Acute on Chronic Liver Failure, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Institute of Liver and Biliary Sciences, India · Phase 2/3, Interventional, and Treatment
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Among 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India — 17 open to participants now, 17 under way, 2 of them phase 3. Acute-On-Chronic Liver Failure · Institute of Liver and Biliary Sciences, India.
Among the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India, this one is the 21st largest by planned enrollment of the 28 interventional ones that give a count, is one of 4 that started in 2025, is the only one in phase 2/3, reaches primary completion later than 4 of the 16 other live ones, and was the 32nd registered.
167 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 62 are open to participants now.
Browse Acute-On-Chronic Liver Failure studies →17 of the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India are open now, in 1 country. Recruiting first, the newest first:
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18+
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–75
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–65
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–65
Institute of Liver and Biliary Sciences, India
Ages 18+
By country, each count listing its studies:
Of the 32 Acute-On-Chronic Liver Failure studies recruiting now, 11 (34%) set no upper age limit and 15 (47%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 3
First in 2011; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 73 across 96 interventional studies indexed under Acute-On-Chronic Liver Failure.
Median enrollment 95 across the 28 interventional studies, 114 across the 11 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
4 of the studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06818565Institute of Liver and Biliary Sciences, IndiaComparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections. | 2026-12-31 |
| NCT07184866Institute of Liver and Biliary Sciences, IndiaVitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial | 2027-07 |
| NCT07178366Institute of Liver and Biliary Sciences, IndiaDouble Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) | 2027-07 |
| NCT07422948Institute of Liver and Biliary Sciences, IndiaEfficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure. | 2027-08-30 |
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Among the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India, from their registry updates:
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Acute portal hypertension, as measured by rapid rise in hepatic venous pressure gradient (HVPG) can lead to further dreaded complications, including acute variceal bleeding (AVB) AVB: 6-week mortality rates of around 15-20% in patients with chronic liver disease without ACLF.The overall prevalence of UGH in cirrhotic patients with AD was 34.4% and 35.7% in patients with ACLF.AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. Medical therapy for esophageal variceal bleeding (EVB) aims to reduce the splanchnic blood flow and portal pressure. The most common vasoactive agents include terlipressin, vasopressin, somatostatin, and octreotide.
Aim and Objective - To assess the safety and efficacy of continuous terlipressin vs. Bolus terlipressin in the management of acute esophageal variceal bleeding in ACLF.
Study population: Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with upper GI bleeding due to esophageal varices Study design: Pilot study Study period: 1 year Sample size: 60
Intervention:
Group I- Intravenous terlipressin (administered as a continuous infusion at 4 mg/24 hours). After 12 hours, if the hepatic venous pressure gradient (HVPG) does not show a reduction of less than 10%, increase the dose to 6 mg/24 hours.
Group II- Intravenous terlipressin (2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs)
Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid
Adverse effects:
Acute Diarrhea, chest pain, Arterial hypertension, Cardiac arrhythmias, Acute abdomen Stopping rule: chest pain, alteration of ECG, cyanosis, bradycardia, severe allergic rashes
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs.
Drug: Terlipressin Injectable Product
Administered as a continuous infusion at 4 mg/24 hours. After 12 hours, if the hepatic venous pressure gradient (HVPG) does not show a reduction of less than 10%, increase the dose to 6 mg/24 hours.
Drug: Terlipressin Injectable Product
Terlipressin Injectable Product
Hepatic venous Pressure Gradient (HVPG) reduction of more than 10% from baseline at 12-24 hours in both arms.
Time frame: 12-24 hours
Failure to control hemostasis
Time frame: 5 days
Terlipressin-related complications within 5 days i.e. safety of the drug
Time frame: 5 days
Number of blood transfusions at 5 days
Time frame: 5 days
Rebleed within 42 day
Time frame: 42 days
Incidence of post-bleed Acute Kidney Injury within 5 days
Time frame: 5 days
6 weeks mortality in both groups.
Time frame: 6 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Feb 2026, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Terlipressin
Acute-On-Chronic Liver Failure →
Institute of Liver and Biliary Sciences, India →