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NCT06772480
Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)
NA trial testing Thalidomide in Liver Cirrhosis in 100 participants. Not yet recruiting.
31 January 2026
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 5 January 2025 |
| Primary completion | 31 January 2026 |
| Estimated completion | 31 January 2026 |
| Sites | 1 location across India |
Drugs / interventions tested
- Thalidomide (THALIDOMIDE) — full drug profile →
- Argon Plasma Coagulation
Conditions studied
- Liver Cirrhosis — all drugs for Liver Cirrhosis →
- Gastric Antral Vascular Ectasia — all drugs for Gastric Antral Vascular Ectasia →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 65, any sex, with Liver Cirrhosis or Gastric Antral Vascular Ectasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06772480
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06772480 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 13 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06772480.
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