Liver CirrhosisNCT06772480
Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)
A study testing Thalidomide and Argon Plasma Coagulation in people with Liver Cirrhosis and Gastric Antral Vascular Ectasia, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Gastric Antral Vascular Ectasia (GAVE) is an erosive form of gastritis distinguished by veno-capillary ectasia, which manifests as tortuous columns of dilated vessels. Histologically, these vessels show dilated mucosal capillaries filled with fibrin thrombi, accompanied by fibromuscular hyperplasia and spindle cell… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis, Gastric Antral Vascular Ectasia
- What is being tested?
- Thalidomide and Argon Plasma Coagulation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 5 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients (aged ≥18 - 65years)
- Cirrhosis
- Endoscopically confirmed diagnosis of GAVE
- +/- GAVE with active ooze
- Iron deficiency anemia*
- Ability to provide informed consent
Who cannot join
- CTP >/=13
- Active GI Bleeding is caused by a cause other than GAVE.
- Renal insufficiency ( Creatinine >3mg/dL and/or on RRT)
- Pregnancy or childbearing age
- Contraindications to thalidomide therapy: Severe peripheral neuropathy or seizures or a history of thromboembolic disease.
- Use of antiangiogenic drugs
Show all 11Show fewer
- Bevacizumab, steroids, octreotide
- Severe cardiopulmonary disorders
- H/o thalidomide use in the past 3months
- Contraindications to APC: Coagulopathy( Pacemaker or implantable defibrillator, Platelet <45000, INR: >1.8 )
- Overt Hepatic Encephalopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Aakula Suguna Sree, MD, 01146300000, sugunasreeaakula@gmail.com
About this study
Official title: Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)- A Randomised Controlled Trial
Gastric Antral Vascular Ectasia (GAVE) is an erosive form of gastritis distinguished by veno-capillary ectasia, which manifests as tortuous columns of dilated vessels. Histologically, these vessels show dilated mucosal capillaries filled with fibrin thrombi, accompanied by fibromuscular hyperplasia and spindle cell proliferation of the lamina propria. GAVE is prevalent in about 12% of patients with cirrhosis, with 60-70% of these patients becoming transfusion-dependent due to severe anaemia caused by GAVE related bleeding. The most commonly used treatment for GAVE is endoscopic therapy using Argon Plasma Coagulation (APC), which, while effective, often requires multiple sessions due to a high recurrence rate of 30-60%. These frequent interventions increase the burden on patients and healthcare systems. As a result, alternative treatments have been sought. Thalidomide, known for its potent antiangiogenic properties, significantly lowers vascular endothelial growth factor (VEGF) levels, offering a promising non-invasive treatment option. Early studies, such as those by García-Pagán have demonstrated thalidomide's effectiveness in reducing transfusion requirements and managing bleeding in cirrhotic patients with GAVE, yet its comprehensive efficacy and safety profile remains under-studied. This project aims to rigorously evaluate the efficacy and safety of thalidomide compared to APC in managing GAVE-related anemia in cirrhotic patients. Through a controlled trial, this study will provide vital data to potentially shift treatment paradigms, enhance patient quality of life, and reduce the need for repetitive invasive procedures.
Read the detailed description
Aim: To evaluate and compare the efficacy and safety of thalidomide with argon plasma coagulation (APC) in managing gastric antral vascular ectasia (GAVE)-related anaemia in patients with cirrhosis.
Hypothesis: Thalidomide, due to its antiangiogenic effects, will more effectively reduce GAVE-related bleeding, improve haemoglobin levels, and decrease transfusion dependency compared to APC in patients with cirrhosis and GAVE-related anaemia.
Study Design:
Single-centre, open-label, randomised controlled trial to compare the efficacy and safety of thalidomide versus argon plasma coagulation (APC) in managing GAVE-related anaemia in cirrhotic patients.
Study Population:
Adult patients (aged 18-65 years) diagnosed with cirrhosis and endoscopically confirmed GAVE-related anaemia, presenting at the Institute of Liver and Biliary Sciences.
Randomization: Patients will be randomly assigned to receive either thalidomide or APC in a 1:1 ratio by block randomization method with block size of 10 and it will be implemented by using ILBS IWRS facility.
Follow-up and Assessments:
- Patients will be followed every two weeks for the first month, then monthly up to six months. Assessments will include haemoglobin levels, the number of transfused blood units, the frequency of bleeding episodes, hospitalizations, and the number of required endoscopic sessions.
- Adverse effects will be monitored and recorded at each visit.
- Conditions
- Liver Cirrhosis, Gastric Antral Vascular Ectasia
- Being tested
- Thalidomide, Argon Plasma Coagulation
- Medical subject headings
- Liver Cirrhosis, Gastric Antral Vascular Ectasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Patients will receive oral thalidomide starting at 50 mg daily, with a weekly increase of 50 mg up to a maximum of 200 mg daily, continued for four months
Argon Plasma CoagulationProcedure or surgery
Patients will undergo APC treatment every 2-3 weeks initially, followed by maintenance sessions every three months as required.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide Group | Experimental | Patients will receive oral thalidomide starting at 50 mg daily, with a weekly increase of 50 mg up to a maximum of 200 mg daily, continued for four months. Receives: Drug: Thalidomide |
| APC Group | Active comparator | Patients will undergo APC treatment every 2-3 weeks initially, followed by maintenance sessions every three months as required. Receives: Procedure: Argon Plasma Coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean increase in hemoglobin levels from baseline
Measured: 4 months
Secondary outcomes (13)
Atleast 50 percent change in requirement of PRBCs transfusions at the end of 4 months
Measured: 4 months
Increase in serum iron levels, percent transferrin saturation at the end of 4months
Measured: 4 months
Change in amount of PRBC's transfused at the end of 4 months.
Measured: 4 months
Change in GAVE related bleeding episodes at the end of 4 months
Measured: 4 months
Number of hospitalizations due to GAVE related anemia, in 4 months
Measured: 4 months
Duration of days of hospitalization due to GAVE related anemia in 4 months
Measured: 4 months
Need of rescue endoscopic sessions in 4 months in thalidomide group
Measured: 4 months
Endoscopic resolution of GAVE at the end of 4 months
Endoscopic resolution is defined as endoscopic findings of GAVE as absent.
Measured: 4 months
Change in VEGF levels in Thalidomide group at the end of 4 months
Measured: 4 months
Change in pepsinogen levels in Thalidomide group at the end of 4 months
Measured: 4 months
Change in gastrin levels in Thalidomide group at the end of 4 months
Measured: 4 months
Adverse events in each group at the end of 4 months
Measured: 4 months
Quality of life measures - Short Form 36
Quality of life measures - Short Form 36 ranges from 0 to 100, 0 indicate maximum disability and 100 indicate no disability.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start5 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772480
- Sponsor's protocol ID
- ILBS-Cirrhosis-70
- Status last verified
- Dec 2024
- First submitted
- 1 Jan 2025
- Last updated
- 13 Jan 2025
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)- A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06772480
- Acronym / sponsor ID
- ILBS-Cirrhosis-70
- Conditions
- Liver Cirrhosis, Gastric Antral Vascular Ectasia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 5 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 13 Jan 2025 (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.
Gastric Antral Vascular Ectasia (GAVE) is an erosive form of gastritis distinguished by veno-capillary ectasia, which manifests as tortuous columns of dilated vessels. Histologically, these vessels show dilated mucosal capillaries filled with fibrin thrombi, accompanied by fibromuscular hyperplasia and spindle cell proliferation of the lamina propria. GAVE is prevalent in about 12% of patients with cirrhosis, with 60-70% of these patients becoming transfusion-dependent due to severe anaemia caused by GAVE related bleeding. The most commonly used treatment for GAVE is endoscopic therapy using Argon Plasma Coagulation (APC), which, while effective, often requires multiple sessions due to a high recurrence rate of 30-60%. These frequent interventions increase the burden on patients and healthcare systems. As a result, alternative treatments have been sought. Thalidomide, known for its potent antiangiogenic properties, significantly lowers vascular endothelial growth factor (VEGF) levels, offering a promising non-invasive treatment option. Early studies, such as those by García-Pagán have demonstrated thalidomide's effectiveness in reducing transfusion requirements and managing bleeding in cirrhotic patients with GAVE, yet its comprehensive efficacy and safety profile remains under-studied. This project aims to rigorously evaluate the efficacy and safety of thalidomide compared to APC in managing GAVE-related anemia in cirrhotic patients. Through a controlled trial, this study will provide vital data to potentially shift treatment paradigms, enhance patient quality of life, and reduce the need for repetitive invasive procedures.
Detailed description
Aim: To evaluate and compare the efficacy and safety of thalidomide with argon plasma coagulation (APC) in managing gastric antral vascular ectasia (GAVE)-related anaemia in patients with cirrhosis.
Hypothesis: Thalidomide, due to its antiangiogenic effects, will more effectively reduce GAVE-related bleeding, improve haemoglobin levels, and decrease transfusion dependency compared to APC in patients with cirrhosis and GAVE-related anaemia.
Study Design:
Single-centre, open-label, randomised controlled trial to compare the efficacy and safety of thalidomide versus argon plasma coagulation (APC) in managing GAVE-related anaemia in cirrhotic patients.
Study Population:
Adult patients (aged 18-65 years) diagnosed with cirrhosis and endoscopically confirmed GAVE-related anaemia, presenting at the Institute of Liver and Biliary Sciences.
Randomization: Patients will be randomly assigned to receive either thalidomide or APC in a 1:1 ratio by block randomization method with block size of 10 and it will be implemented by using ILBS IWRS facility.
Follow-up and Assessments:
- Patients will be followed every two weeks for the first month, then monthly up to six months. Assessments will include haemoglobin levels, the number of transfused blood units, the frequency of bleeding episodes, hospitalizations, and the number of required endoscopic sessions.
- Adverse effects will be monitored and recorded at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thalidomide Group | Experimental | Drug: ThalidomidePatients will receive oral thalidomide starting at 50 mg daily, with a weekly increase of 50 mg up to a maximum of 200 mg daily, continued for four months. |
| APC Group | Active comparator | Procedure: Argon Plasma CoagulationPatients will undergo APC treatment every 2-3 weeks initially, followed by maintenance sessions every three months as required. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (aged ≥18 - 65years)
- Cirrhosis
- Endoscopically confirmed diagnosis of GAVE
- Ability to provide informed consent
Key exclusion criteria (11 listed)
- CTP >/=13
- Active GI Bleeding is caused by a cause other than GAVE.
- Renal insufficiency ( Creatinine >3mg/dL and/or on RRT)
- Pregnancy or childbearing age
- Contraindications to thalidomide therapy: Severe peripheral neuropathy or seizures or a history of thromboembolic disease.
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 |
|---|---|---|
| ThalidomidePatients will receive oral thalidomide starting at 50 mg daily, with a weekly increase of 50 mg up to a maximum of 200 mg daily, continued for four months | Drug | Thalidomide Group |
| Argon Plasma CoagulationPatients will undergo APC treatment every 2-3 weeks initially, followed by maintenance sessions every three months as required. | Procedure or surgery | APC Group |
Primary outcome
Mean increase in hemoglobin levels from baseline
Time frame: 4 months
13 secondary outcomes
Atleast 50 percent change in requirement of PRBCs transfusions at the end of 4 months
Time frame: 4 months
Increase in serum iron levels, percent transferrin saturation at the end of 4months
Time frame: 4 months
Change in amount of PRBC's transfused at the end of 4 months.
Time frame: 4 months
Change in GAVE related bleeding episodes at the end of 4 months
Time frame: 4 months
Number of hospitalizations due to GAVE related anemia, in 4 months
Time frame: 4 months
Duration of days of hospitalization due to GAVE related anemia in 4 months
Time frame: 4 months
Need of rescue endoscopic sessions in 4 months in thalidomide group
Time frame: 4 months
Endoscopic resolution of GAVE at the end of 4 months
Time frame: 4 months
Change in VEGF levels in Thalidomide group at the end of 4 months
Time frame: 4 months
Change in pepsinogen levels in Thalidomide group at the end of 4 months
Time frame: 4 months
Change in gastrin levels in Thalidomide group at the end of 4 months
Time frame: 4 months
Adverse events in each group at the end of 4 months
Time frame: 4 months
Quality of life measures - Short Form 36
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thalidomide and Argon Plasma Coagulation in people with Liver Cirrhosis and Gastric Antral Vascular Ectasia, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 13 Jan 2025. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Aakula Suguna Sree, MD (01146300000, sugunasreeaakula@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean increase in hemoglobin levels from baseline (time frame: 4 months). 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 13 Jan 2025.