Terlipressin Adverse ReactionPhase 3TTNCT04028505
Terlipressin Infusion in Variceal Hemorrhage
A Phase 3 study testing Terlipressin Injectable Product in people with Terlipressin Adverse Reaction, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Randomized, open label study of intravenous terlipressin infusion vs. bolus for the treatment of variceal hemorrhage. 24 hour regimen consisting of intravenous terlipressin will be used either at a rate of 0.5mg/hour or 2mg bolus every 4 hourly. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Terlipressin Adverse Reaction
- What is being tested?
- Terlipressin Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Oct 2018to 25 Oct 2020
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 to 60 years
- Either gender
- A diagnosis of liver cirrhosis;
- Initial presentation with acute gastroesophageal variceal bleeding
- Willing to provide informed consent to participate in the study (by study subject or next of kin)
Who cannot join
- Age < 18 or > 60 years
- Not willing to provide consent due to any reason
- No liver cirrhosis
- Acute upper gastrointestinal bleeding unrelated to varices;
- Use of somatostatin or octreotide.
- Hepatocellular Carcinoma (HCC)outside Milan's criteria
Show all 10Show fewer
- Advance cardiovascular, pulmonary or renal disease (e.g. asthma, hypertension, arrhythmia, renal insufficiency)
- History of hypersensitivity to Terlipressin
- Pregnancy
- Patients already admitted at AKUH who develop upper GI bleed during admission.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh, 74000
Dilshad Begum, MScN, +92213486 ext. 2303, dilshad.begum@aku.edu
shahab Abid, Phd,FRCP
About this study
Official title: Terlipressin Bolus Versus Continuous Infusion in Patients With Variceal Hemorrhage
Randomized, open label study of intravenous terlipressin infusion vs. bolus for the treatment of variceal hemorrhage. 24 hour regimen consisting of intravenous terlipressin will be used either at a rate of 0.5mg/hour or 2mg bolus every 4 hourly. Participants will be randomized into intervention and control arm using block randomization by computer generated random numbers. Efficacy will be assessed by clinical improvement in symptoms and signs of GI bleed. To assess safety, frequency and degree of adverse reactions will be observed. Periodic assessments until 5 days will be done consisting of physical examination, safety assessments, vital signs and lab tests.
Read the detailed description
Randomized, open label trial, conducted on patients admitted with acute variceal hemorrhage at The Aga Khan University Hospital, Karachi (AKUH). Patients will be followed in clinic after discharge to assess survival for 6 weeks.
Intravenous terlipressin will be obtained from Clinical Trials Unit, AKUH pharmacy in standard IV infusion form. Following complete clinical and laboratory evaluation, assessing the patient for eligibility, informed consent will be obtained from all the participants who are willing to be part of this study. After obtaining the informed consent, study participants will be randomized into the intervention arm (continuous infusion of Terlipressin) or the control arm (bolus form of Terlipressin). Participants who are randomized to the intervention arm will be administered a continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours. Participants randomized into the control group will be administered a bolus form of Terlipressin at a rate of 2mg every six hourly for the first 24 hours respectively. In case of weekends/public holidays intravenous terlipressin will be obtained from the main pharmacy of AKUH.
The trial will be conducted in in-patient units of AKUH where eligible patients are admitted. It may include emergency room, special care unit and general ward. Moreover, patients will be followed up by phone calls and in outpatient's clinics to assess survival six weeks post discharge.
- Conditions
- Terlipressin Adverse Reaction
- Being tested
- Terlipressin Injectable Product
- Keywords
- Terlipressin Drug, Continuous Infusion, Bolus Form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terlipressin Injectable ProductDrug
Also called Novapressin
Intravenous terlipressin will be obtained from Clinical Trials Unit, AKUH pharmacy in standard IV infusion form.
Participants who are randomized to the intervention arm will be administered a continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours. Participants randomized into the control group will be administered a bolus form of Terlipressin at a rate of 2mg every six hourly for the first 24 hours respectively. In case of weekends/public holidays intravenous terlipressin will be obtained from the main pharmacy of AKUH.
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin Continuous Infusion | Experimental | Standard of care being given at AKUH + Continuous infusion of Terlipressin (Terlipressin Injectable Product) at a rate of 0.5mg/hour for the first 24 hours Receives: Drug: Terlipressin Injectable Product |
| Terlipressin Bolus Infusion | Active comparator | Standard of care being given at AKUH + Bolus infusion of Terlipressin (Terlipressin Injectable Product) at a frequency of 2mg every six hourly for first 24 hours Receives: Drug: Terlipressin Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in tachycardia, measured through heart rate (>100 bpm) being displayed in the electronic monitors in wards, emergency room and out-patient clinics
It will be assessed by trained research coordinator as; the number of study participants with 20% reduction in tachycardia as compared to the baseline between the two arms.
Measured: 6 weeks (Overall length of follow-up)
Improvement in mean arterial pressure, being displayed in the electronic monitors in wards, emergency room and out-patient clinics
It will be assessed by trained research coordinator as; the number of study participants with 20% improvement in mean arterial pressure as compared to the baseline between the two arms.
Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain; arterial hypertension should be reported to the primary gastroenterologist between the two arms.
Measured: 6 weeks (Overall length of follow-up)
In-patient hospital mortality, assessed through medical records.
It will be assessed through medical records, by a trained research coordinator as the number of study participants dying within the hospital between the two arms.
Measured: Admission of patient till death in the hospital
Failure to control bleeding as assessed by physiological parameters in the blood
It will be assessed by a trained research coordinator as the number of participants having fresh hematemesis and 3 gm drop in hemoglobin (9% drop in hematocrit) within a 24 hours' time period between the two arms.
Measured: Admission of patient till discharge from the hospital
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
It will be assessed by trained research coordinator as; the number of participants having experienced any adverse events such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, 5 days after having terlipressin drug, between the two arms.
Measured: 6 weeks (Overall length of follow-up)
Secondary outcomes (3)
Out of hospital mortality assessed through telephonic interviews from patient's caregiver
It will be assessed by trained research coordinator as; the number of participants dying after being discharged from the hospital between the two arms within the follow-up time period of the study.
Measured: 5 weeks after being discharged from the hospital
Failure to control bleeding as assessed by physiological parameters in the blood
It will be assessed by trained research coordinator as the number of participants having fresh hematemesis and 3 gm drop in hemoglobin (9% drop in hematocrit) after being discharged from the hospital till three subsequent follow-up visits between the two arms.
Measured: 5 weeks after being discharged from the hospital
Prolong hospital stay (> 5 days) as assessed through medical records and pre-designed questionnaire
It will be assessed by trained research coordinator as; the number of participants having stayed in the hospital for more than five days between the two arms.
Measured: 5 days after admission till being discharged from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start25 Oct 2018
- Primary completion25 Apr 2020 (estimated)
- Study completion25 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Terlipressin Adverse ReactionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Arm: Standard of care being given at AKUH + Continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours Comparator Arm: Standard of care being given at AKUH + Bolus infusion of Terlipressin at a frequency of 2mg every six hourly for first 24 hours
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, SHAHAB ABID, Aga Khan University
- Investigators
- Shahab Abid, PhD,FRCP, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028505
- Sponsor's protocol ID
- 5209-Med-ERC-18
- Acronym
- TT
- Status last verified
- Jul 2019
- First submitted
- 10 May 2018
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu Y, Grieme A, Liu KS, Nguyen V, Adamson C, Garza M, Smith ER, Ramai D, Han A, Bushe B, Adler DG. The Efficacy of Single Dose Linaclotide in Polyethylene Glycol-Based Bowel Preparation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Gastroenterol. 2026 May-Jun 01;60(5):424-431. doi: 10.1097/MCG.0000000000002267. Epub 2025 Oct 23.
PubMed 41123247
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terlipressin Bolus Versus Continuous Infusion in Patients With Variceal Hemorrhage
- ClinicalTrials.gov ID
- NCT04028505
- Acronym / sponsor ID
- TT / 5209-Med-ERC-18
- Conditions
- Terlipressin Adverse Reaction
- Keywords
- Terlipressin Drug, Continuous Infusion, Bolus Form
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 25 Apr 2020 (estimated)
- Study completion
- 25 Oct 2020 (estimated)
- First posted
- 22 Jul 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.
Randomized, open label study of intravenous terlipressin infusion vs. bolus for the treatment of variceal hemorrhage. 24 hour regimen consisting of intravenous terlipressin will be used either at a rate of 0.5mg/hour or 2mg bolus every 4 hourly. Participants will be randomized into intervention and control arm using block randomization by computer generated random numbers. Efficacy will be assessed by clinical improvement in symptoms and signs of GI bleed. To assess safety, frequency and degree of adverse reactions will be observed. Periodic assessments until 5 days will be done consisting of physical examination, safety assessments, vital signs and lab tests.
Detailed description
Randomized, open label trial, conducted on patients admitted with acute variceal hemorrhage at The Aga Khan University Hospital, Karachi (AKUH). Patients will be followed in clinic after discharge to assess survival for 6 weeks.
Intravenous terlipressin will be obtained from Clinical Trials Unit, AKUH pharmacy in standard IV infusion form. Following complete clinical and laboratory evaluation, assessing the patient for eligibility, informed consent will be obtained from all the participants who are willing to be part of this study. After obtaining the informed consent, study participants will be randomized into the intervention arm (continuous infusion of Terlipressin) or the control arm (bolus form of Terlipressin). Participants who are randomized to the intervention arm will be administered a continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours. Participants randomized into the control group will be administered a bolus form of Terlipressin at a rate of 2mg every six hourly for the first 24 hours respectively. In case of weekends/public holidays intravenous terlipressin will be obtained from the main pharmacy of AKUH.
The trial will be conducted in in-patient units of AKUH where eligible patients are admitted. It may include emergency room, special care unit and general ward. Moreover, patients will be followed up by phone calls and in outpatient's clinics to assess survival six weeks post discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental Arm: Standard of care being given at AKUH + Continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours Comparator Arm: Standard of care being given at AKUH + Bolus infusion of Terlipressin at a frequency of 2mg every six hourly for first 24 hours
| Arm | Type | Receives |
|---|---|---|
| Terlipressin Continuous Infusion | Experimental | Drug: Terlipressin Injectable ProductStandard of care being given at AKUH + Continuous infusion of Terlipressin (Terlipressin Injectable Product) at a rate of 0.5mg/hour for the first 24 hours |
| Terlipressin Bolus Infusion | Active comparator | Drug: Terlipressin Injectable ProductStandard of care being given at AKUH + Bolus infusion of Terlipressin (Terlipressin Injectable Product) at a frequency of 2mg every six hourly for first 24 hours |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 to 60 years
- Either gender
- A diagnosis of liver cirrhosis;
- Initial presentation with acute gastroesophageal variceal bleeding
- Willing to provide informed consent to participate in the study (by study subject or next of kin)
Key exclusion criteria (10 listed)
- Age < 18 or > 60 years
- Not willing to provide consent due to any reason
- No liver cirrhosis
- Acute upper gastrointestinal bleeding unrelated to varices;
- Use of somatostatin or octreotide.
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 |
|---|---|---|
| Terlipressin Injectable ProductAlso: NovapressinIntravenous terlipressin will be obtained from Clinical Trials Unit, AKUH pharmacy in standard IV infusion form. Participants who are randomized to the intervention arm will be administered a continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours. Participants randomized into the control group will be administered a bolus form of Terlipressin at a rate of 2mg every six hourly for the first 24 hours respectively. In case of weekends/public holidays intravenous terlipressin will be obtained from the main pharmacy of AKUH. | Drug | Terlipressin Bolus Infusion, Terlipressin Continuous Infusion |
Primary outcome
Reduction in tachycardia, measured through heart rate (>100 bpm) being displayed in the electronic monitors in wards, emergency room and out-patient clinics
Time frame: 6 weeks (Overall length of follow-up)
It will be assessed by trained research coordinator as; the number of study participants with 20% reduction in tachycardia as compared to the baseline between the two arms.
Improvement in mean arterial pressure, being displayed in the electronic monitors in wards, emergency room and out-patient clinics
Time frame: 6 weeks (Overall length of follow-up)
It will be assessed by trained research coordinator as; the number of study participants with 20% improvement in mean arterial pressure as compared to the baseline between the two arms. Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain; arterial hypertension should be reported to the primary gastroenterologist between the two arms.
In-patient hospital mortality, assessed through medical records.
Time frame: Admission of patient till death in the hospital
It will be assessed through medical records, by a trained research coordinator as the number of study participants dying within the hospital between the two arms.
Failure to control bleeding as assessed by physiological parameters in the blood
Time frame: Admission of patient till discharge from the hospital
It will be assessed by a trained research coordinator as the number of participants having fresh hematemesis and 3 gm drop in hemoglobin (9% drop in hematocrit) within a 24 hours' time period between the two arms.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 6 weeks (Overall length of follow-up)
It will be assessed by trained research coordinator as; the number of participants having experienced any adverse events such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, 5 days after having terlipressin drug, between the two arms.
3 secondary outcomes
Out of hospital mortality assessed through telephonic interviews from patient's caregiver
Time frame: 5 weeks after being discharged from the hospital
Failure to control bleeding as assessed by physiological parameters in the blood
Time frame: 5 weeks after being discharged from the hospital
Prolong hospital stay (> 5 days) as assessed through medical records and pre-designed questionnaire
Time frame: 5 days after admission till being discharged from the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Derived from this study: PubMed 41123247Wu Y, Grieme A, Liu KS, Nguyen V, Adamson C, Garza M, Smith ER, Ramai D, Han A, Bushe B, Adler DG. The Efficacy of Single Dose Linaclotide in Polyethylene Glycol-Based Bowel Preparation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Gastroenterol. 2026 May-Jun 01;60(5):424-431. doi: 10.1097/MCG.0000000000002267. Epub 2025 Oct 23.
- Individual participant dataSharing planned: No
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.
Shahab Abid, PhD,FRCP principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Terlipressin Injectable Product in people with Terlipressin Adverse Reaction, run by Aga Khan University 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 5 inclusion and 10 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 22 Jul 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shahab Abid, Phd,FRCP (+92213486 ext. 4656, shahab.abid@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in tachycardia, measured through heart rate (>100 bpm) being displayed in the electronic monitors in wards, emergency room and out-patient clinics (time frame: 6 weeks (Overall length of follow-up)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04028505, which also lists 1 linked publication.
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 22 Jul 2019.