Liver Cirrhosis PortalPhase 4INFUTERNCT04353193
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
A Phase 4 study testing Terlipressin and Octreotide in people with Liver Cirrhosis Portal, run by Juan A. Arnaiz at 1 site in Spain.
Trial summary
Clinical trial to compare the effects of terlipressin and octreotide in the reduction of portal hypertension measured as hepatic venous pressure gradient (HVPG) in patients with liver cirrhosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis Portal
- What is being tested?
- Terlipressin and Octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2020to May 2022
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old.
- Liver Cirrhosis
- Portal hypertension
- Stable disease in the absence of vasoactive agents
- Signed informed consent form
Who cannot join
- 1. Patients on medications that can prolong QT interval 2. Patients with HCC not fulfilling Milan criteria for transplant 3. Grade II-IV hepatic encephalopathy 4. GI bleeding in the last 10 days 5. Child-Pugh C above 12 points 6. Bacterial infection in the last 10 days 7. HVPG <12mmHg 8. Plasma sodium <130mmol/l 9. Serum creatinine >2mg/dl 10. Serum bilirubin >5mg/dl 11. INR>2.5 12. Uncontrolled cardiovascular disease 13. HIV infection 14. Extra hepatic malignancies 15. Heart failure NYHA Grade III/IV, COPD GOLD>2 16. Morbid obesity 17. Coronary heart disease or intestinal ischemia 18. Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Clinical trial to compare the effects of terlipressin and octreotide in the reduction of portal hypertension measured as hepatic venous pressure gradient (HVPG) in patients with liver cirrhosis
- Conditions
- Liver Cirrhosis Portal
- Being tested
- Terlipressin, Octreotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Terlipressin 1mg IV bolus
TerlipressinDrug
Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours
OctreotideDrug
Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin IV bolus | Experimental | Terlipressin 1mg IV bolus Receives: Drug: Terlipressin |
| Terlipressin IV continuous infusion | Experimental | Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours Receives: Drug: Terlipressin |
| Octreotide IV bolus plus continuous infusion | Experimental | Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours Receives: Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HVPG
Measured: 30 minutes, 1 hour and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study startJun 2020 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cirrhosis PortalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353193
- Sponsor's protocol ID
- INFUTER
- Other IDs
- 2019-004328-39, 2019
- Acronym
- INFUTER
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT04353193
- Acronym / sponsor ID
- INFUTER / INFUTER
- Conditions
- Liver Cirrhosis Portal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 20 Apr 2020 (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.
Clinical trial to compare the effects of terlipressin and octreotide in the reduction of portal hypertension measured as hepatic venous pressure gradient (HVPG) in patients with liver cirrhosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terlipressin IV bolus | Experimental | Drug: TerlipressinTerlipressin 1mg IV bolus |
| Terlipressin IV continuous infusion | Experimental | Drug: TerlipressinTerlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours |
| Octreotide IV bolus plus continuous infusion | Experimental | Drug: OctreotideOctreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-75 years old.
- Liver Cirrhosis
- Portal hypertension
- Stable disease in the absence of vasoactive agents
- Signed informed consent form
Key exclusion criteria (1 listed)
- 1. Patients on medications that can prolong QT interval 2. Patients with HCC not fulfilling Milan criteria for transplant 3. Grade II-IV hepatic encephalopathy 4. GI bleeding in the last 10 days 5. Child-Pugh C above 12 points 6. Bacterial infection in the last 10 days 7. HVPG <12mmHg 8. Plasma sodium <130mmol/l 9. Serum creatinine >2mg/dl 10. Serum bilirubin >5mg/dl 11. INR>2.5 12. Uncontrolled cardiovascular disease 13. HIV infection 14. Extra hepatic malignancies 15. Heart failure NYHA Grade III/IV, COPD GOLD>2 16. Morbid obesity 17. Coronary heart disease or intestinal ischemia 18. Pregnancy or breastfeeding
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 |
|---|---|---|
| TerlipressinTerlipressin 1mg IV bolus | Drug | Terlipressin IV bolus |
| TerlipressinTerlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours | Drug | Terlipressin IV continuous infusion |
| OctreotideOctreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours | Drug | Octreotide IV bolus plus continuous infusion |
Primary outcome
Change in HVPG
Time frame: 30 minutes, 1 hour and 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Terlipressin and Octreotide in people with Liver Cirrhosis Portal, run by Juan A. Arnaiz at 1 site in Spain.
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 1 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 20 Apr 2020. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Juan Carlos Garcia-Pagan, MD (+34932275400 ext. 5790, jcgarcia@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HVPG (time frame: 30 minutes, 1 hour and 2 hours). 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 20 Apr 2020.