Hepatorenal SyndromeNCT07460908
Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome
A study testing terlipressin and Octreotide (drug) in people with Hepatorenal Syndrome, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
Hepatorenal syndrome is a serious complication of advanced liver disease in which kidney function rapidly worsens and can lead to life-threatening illness. Effective treatment is essential because delayed improvement in kidney function is associated with poor short-term outcomes. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hepatorenal Syndrome
- What is being tested?
- terlipressin and Octreotide (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 30 Oct 2025
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 to 70 years
- Either gender
- Diagnosed with hepatorenal syndrome
Who cannot join
- Hepatocellular carcinoma
- Septic shock
- Cardiac failure
- Respiratory failure
- Stroke
- Coronary artery disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
Hepatorenal syndrome is a serious complication of advanced liver disease in which kidney function rapidly worsens and can lead to life-threatening illness. Effective treatment is essential because delayed improvement in kidney function is associated with poor short-term outcomes. This randomized controlled trial will compare two commonly used medicines, terlipressin and octreotide, for the treatment of hepatorenal syndrome in adult patients admitted to Medical Unit III, Lahore General Hospital, Lahore. A total of 60 eligible patients (30 to 70 years of age) will be enrolled using consecutive sampling and randomly allocated in a 1:1 ratio to receive either terlipressin or octreotide according to the study protocol. The main study outcome will be treatment response within 48 hours, assessed by change in serum creatinine. Response will be categorized as complete (serum creatinine less than 1.5 mg/dL at 48 hours), partial (more than 50% reduction from baseline but serum creatinine remains above 1.5 mg/dL), or no response (less than 50% reduction from baseline). It is hypothesized that there is a difference in the clinical response between terlipressin and octreotide in patients with hepatorenal syndrome.
- Conditions
- Hepatorenal Syndrome
- Being tested
- terlipressin, Octreotide (drug)
- Keywords
- Advanced liver disease, Acute kidney injury, Serum creatinine, Vasoconstrictor therapy, Terlipressin, Octreotide
- Medical subject headings
- Hepatorenal Syndrome, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terlipressinDrug
Also called Terlipressin acetate
Dose and route: 2 mg intravenous bolus, followed by 1 mg intravenously every 6 hours Treatment duration for primary assessment: 48 hours
Octreotide (drug)Drug
Also called Octreotide acetate
Dose and route: 100 micrograms intravenous bolus, prepared as 1 microgram per 1 mL in 0.45% dextrose saline
Treatment duration for primary assessment: 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Group Terlipressin | Experimental | Participants will receive terlipressin as per study protocol for the treatment of hepatorenal syndrome. Receives: Drug: terlipressin |
| Group Octreotide | Active comparator | Participants will receive octreotide as per study protocol for the treatment of hepatorenal syndrome. Receives: Drug: Octreotide (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response based on serum creatinine at 48 hours
Treatment response will be assessed using the change in serum creatinine from baseline to 48 hours after initiation of study drug. Response will be categorized as:
Complete response: serum creatinine < 1.5 mg/dL at 48 hours Partial response: > 50% decrease in serum creatinine from baseline, but serum creatinine remains > 1.5 mg/dL at 48 hours No response: < 50% decrease in serum creatinine from baseline at 48 hours
Measured: Baseline and 48 hours after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 May 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatorenal SyndromeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Muhammad Hasnain, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460908
- Sponsor's protocol ID
- LahoreGeneralH15
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome
- ClinicalTrials.gov ID
- NCT07460908
- Acronym / sponsor ID
- LahoreGeneralH15
- Conditions
- Hepatorenal Syndrome
- Keywords
- Advanced liver disease, Acute kidney injury, Serum creatinine, Vasoconstrictor therapy, Terlipressin, Octreotide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 10 Mar 2026 (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.
Hepatorenal syndrome is a serious complication of advanced liver disease in which kidney function rapidly worsens and can lead to life-threatening illness. Effective treatment is essential because delayed improvement in kidney function is associated with poor short-term outcomes. This randomized controlled trial will compare two commonly used medicines, terlipressin and octreotide, for the treatment of hepatorenal syndrome in adult patients admitted to Medical Unit III, Lahore General Hospital, Lahore. A total of 60 eligible patients (30 to 70 years of age) will be enrolled using consecutive sampling and randomly allocated in a 1:1 ratio to receive either terlipressin or octreotide according to the study protocol. The main study outcome will be treatment response within 48 hours, assessed by change in serum creatinine. Response will be categorized as complete (serum creatinine less than 1.5 mg/dL at 48 hours), partial (more than 50% reduction from baseline but serum creatinine remains above 1.5 mg/dL), or no response (less than 50% reduction from baseline). It is hypothesized that there is a difference in the clinical response between terlipressin and octreotide in patients with hepatorenal syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Terlipressin | Experimental | Drug: terlipressinParticipants will receive terlipressin as per study protocol for the treatment of hepatorenal syndrome. |
| Group Octreotide | Active comparator | Drug: Octreotide (drug)Participants will receive octreotide as per study protocol for the treatment of hepatorenal syndrome. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 30 to 70 years
- Either gender
- Diagnosed with hepatorenal syndrome
Key exclusion criteria (6 listed)
- Hepatocellular carcinoma
- Septic shock
- Cardiac failure
- Respiratory failure
- Stroke
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 |
|---|---|---|
| terlipressinAlso: Terlipressin acetateDose and route: 2 mg intravenous bolus, followed by 1 mg intravenously every 6 hours Treatment duration for primary assessment: 48 hours | Drug | Group Terlipressin |
| Octreotide (drug)Also: Octreotide acetateDose and route: 100 micrograms intravenous bolus, prepared as 1 microgram per 1 mL in 0.45% dextrose saline Treatment duration for primary assessment: 48 hours | Drug | Group Octreotide |
Primary outcome
Treatment response based on serum creatinine at 48 hours
Time frame: Baseline and 48 hours after initiation of treatment
Treatment response will be assessed using the change in serum creatinine from baseline to 48 hours after initiation of study drug. Response will be categorized as: Complete response: serum creatinine < 1.5 mg/dL at 48 hours Partial response: > 50% decrease in serum creatinine from baseline, but serum creatinine remains > 1.5 mg/dL at 48 hours No response: < 50% decrease in serum creatinine from baseline at 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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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.
Muhammad Hasnain principal investigator
Lahore General Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing terlipressin and Octreotide (drug) in people with Hepatorenal Syndrome, run by Lahore General Hospital at 1 site in Pakistan.
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 6 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: finished, as of the sponsor's last update on 10 Mar 2026. 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 Pakistan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment response based on serum creatinine at 48 hours (time frame: Baseline and 48 hours after initiation of treatment). 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 10 Mar 2026.