Decompensated CirrhosisPhase 2/3NCT01440829
The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS
A Phase 2/3 study testing L-ornithine-L-aspartate in people with Decompensated Cirrhosis and Portal Hypertension, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Decompensated Cirrhosis, Portal Hypertension, Bleeding Varices
- What is being tested?
- L-ornithine-L-aspartate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2012
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients with refractory ascites or at least one episode of variceal bleeding
- No active bleeding within 5 days before TIPS
- Child-Pugh score ≤ 11
- Signed written informed consent
Who cannot join
- An age < 18 years or > 65 years
- With TIPS contraindications
- Using drugs for hepatic encephalopathy such as neomycin, rifaximin, lactulose, lactitol or branched-chain amino acid.
- Intake of psychostimulants, sedatives, antidepressants, benzodiazepines or benzodiazepine-antagonists
- Past or present history of hepatic encephalopathy
- Pregnancy or breast-feeding
Show all 15Show fewer
- Hepatic carcinoma and/or other malignancy diseases
- Sepsis
- Spontaneous bacterial peritonitis
- Uncontrollable hypertension
- Serious cardiac or pulmonary dysfunction
- Renal failure
- Portal vein thrombosis
- History of organ transplantation
- History of HIV (human immunodeficiency viruses) infection
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: The Effectiveness of L-ornithine-L-aspartate on Plasma Ammonia in Cirrhotic Patients After TIPS Procedure: a Prospective, Randomized, Controlled, Open-label Clinical Trial
The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.
Read the detailed description
Patients with successful TIPS deployment are randomized to LOLA arm and blank control arm. Plasma ammonia concentrations are measured before TIPS, day 1, day 4 and day 7 after TIPS.
- Being tested
- L-ornithine-L-aspartate
- Keywords
- Transjugular Intrahepatic Portosystemic Shunt, TIPS, Liver Cirrhosis, LOLA, L-ornithine-L-aspartate, Refractory Ascites
- Medical subject headings
- Hypertension, Portal, Ascites, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-ornithine-L-aspartateDrug
The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
| Study group | Role | What they receive |
|---|---|---|
| LOLA group | Experimental | Intervention: LOLA (30g per day) for a week. Receives: Drug: L-ornithine-L-aspartate |
| Control group | No intervention | Patients will not be treated with LOLA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma ammonia
The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.
Measured: One week
Secondary outcomes (3)
Incidence of hepatic encephalopathy
Measured: One week
Liver function
The liver function (includes PT/INR, APTT, albumin, bilirubin, Child-Pugh score) at the first, fourth and seventh days after TIPS procedure.
Measured: One week
Psychometric tests
The results of the psychometric tests (include number connection test A, number connection test B, digit symbol test, serial dotting test, line tracing test) at the first, fourth and seventh days after TIPS procedure.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Decompensated CirrhosisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Han, Air Force Military Medical University, China
- Investigators
- Guohong Han, PhD & MD, Principal investigator, Xijing Hospital of Digestive Diseases, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440829
- Sponsor's protocol ID
- LOLA-TIPS
- Status last verified
- Dec 2012
- First submitted
- 21 Sep 2011
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stauch S, Kircheis G, Adler G, Beckh K, Ditschuneit H, Gortelmeyer R, Hendricks R, Heuser A, Karoff C, Malfertheiner P, Mayer D, Rosch W, Steffens J. Oral L-ornithine-L-aspartate therapy of chronic hepatic encephalopathy: results of a placebo-controlled double-blind study. J Hepatol. 1998 May;28(5):856-64. doi: 10.1016/s0168-8278(98)80237-7.
PubMed 9625322Rose C, Michalak A, Rao KV, Quack G, Kircheis G, Butterworth RF. L-ornithine-L-aspartate lowers plasma and cerebrospinal fluid ammonia and prevents brain edema in rats with acute liver failure. Hepatology. 1999 Sep;30(3):636-40. doi: 10.1002/hep.510300311.
PubMed 10462368Rees CJ, Oppong K, Al Mardini H, Hudson M, Record CO. Effect of L-ornithine-L-aspartate on patients with and without TIPS undergoing glutamine challenge: a double blind, placebo controlled trial. Gut. 2000 Oct;47(4):571-4. doi: 10.1136/gut.47.4.571.
PubMed 10986219Nolte W, Wiltfang J, Schindler C, Munke H, Unterberg K, Zumhasch U, Figulla HR, Werner G, Hartmann H, Ramadori G. Portosystemic hepatic encephalopathy after transjugular intrahepatic portosystemic shunt in patients with cirrhosis: clinical, laboratory, psychometric, and electroencephalographic investigations. Hepatology. 1998 Nov;28(5):1215-25. doi: 10.1002/hep.510280508.
PubMed 9794904
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of L-ornithine-L-aspartate on Plasma Ammonia in Cirrhotic Patients After TIPS Procedure: a Prospective, Randomized, Controlled, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT01440829
- Acronym / sponsor ID
- LOLA-TIPS
- Keywords
- Transjugular Intrahepatic Portosystemic Shunt, TIPS, Liver Cirrhosis, LOLA, L-ornithine-L-aspartate, Refractory Ascites
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Sep 2011 (estimated)
- 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.
The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.
Detailed description
Patients with successful TIPS deployment are randomized to LOLA arm and blank control arm. Plasma ammonia concentrations are measured before TIPS, day 1, day 4 and day 7 after TIPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOLA group | Experimental | Drug: L-ornithine-L-aspartateIntervention: LOLA (30g per day) for a week. |
| Control group | No intervention | –Patients will not be treated with LOLA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhotic patients with refractory ascites or at least one episode of variceal bleeding
- No active bleeding within 5 days before TIPS
- Child-Pugh score ≤ 11
- Signed written informed consent
Key exclusion criteria (15 listed)
- An age < 18 years or > 65 years
- With TIPS contraindications
- Using drugs for hepatic encephalopathy such as neomycin, rifaximin, lactulose, lactitol or branched-chain amino acid.
- Intake of psychostimulants, sedatives, antidepressants, benzodiazepines or benzodiazepine-antagonists
- Past or present history of hepatic encephalopathy
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 |
|---|---|---|
| L-ornithine-L-aspartateThe patients will be treated with LOLA (30g per day) for a week after TIPS procedure. | Drug | LOLA group |
Primary outcome
Plasma ammonia
Time frame: One week
The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.
3 secondary outcomes
Incidence of hepatic encephalopathy
Time frame: One week
Liver function
Time frame: One week
Psychometric tests
Time frame: One week
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 19 Dec 2012.
- Background: PubMed 9625322Stauch S, Kircheis G, Adler G, Beckh K, Ditschuneit H, Gortelmeyer R, Hendricks R, Heuser A, Karoff C, Malfertheiner P, Mayer D, Rosch W, Steffens J. Oral L-ornithine-L-aspartate therapy of chronic hepatic encephalopathy: results of a placebo-controlled double-blind study. J Hepatol. 1998 May;28(5):856-64. doi: 10.1016/s0168-8278(98)80237-7.
- Background: PubMed 10462368Rose C, Michalak A, Rao KV, Quack G, Kircheis G, Butterworth RF. L-ornithine-L-aspartate lowers plasma and cerebrospinal fluid ammonia and prevents brain edema in rats with acute liver failure. Hepatology. 1999 Sep;30(3):636-40. doi: 10.1002/hep.510300311.
- Background: PubMed 10986219Rees CJ, Oppong K, Al Mardini H, Hudson M, Record CO. Effect of L-ornithine-L-aspartate on patients with and without TIPS undergoing glutamine challenge: a double blind, placebo controlled trial. Gut. 2000 Oct;47(4):571-4. doi: 10.1136/gut.47.4.571.
- Background: PubMed 9794904Nolte W, Wiltfang J, Schindler C, Munke H, Unterberg K, Zumhasch U, Figulla HR, Werner G, Hartmann H, Ramadori G. Portosystemic hepatic encephalopathy after transjugular intrahepatic portosystemic shunt in patients with cirrhosis: clinical, laboratory, psychometric, and electroencephalographic investigations. Hepatology. 1998 Nov;28(5):1215-25. doi: 10.1002/hep.510280508.
Related trials for Decompensated Cirrhosis
Enrolling by invitationPhase 4
Low Dose Versus Standard Dose Albumin
Decompensated Cirrhosis and Ascites
Not yet recruitingObservational study
Risk Stratification for Adverse Events in End-Stage Liver Disease
Decompensated Cirrhosis
RecruitingObservational study
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Ascites, Variceal Bleeding
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Recruiting
Hospital @ Home Model of Care for Cirrhosis
Decompensated Cirrhosis
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.
Guohong Han, PhD & MD principal investigator
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing L-ornithine-L-aspartate in people with Decompensated Cirrhosis and Portal Hypertension, run by Air Force Military Medical University, China at 1 site in China.
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: finished, as of the sponsor's last update on 19 Dec 2012. 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 China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Plasma ammonia (time frame: One week). 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 NCT01440829, which also lists 4 linked publications.
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 19 Dec 2012.