Pentoxifylline Plus Carvedilol vs Carvedilol Monotherapy in Preventing New Decompensation in Stable Cirrhotic Patients With Prior Decompensation
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ClinicalTrials.gov Identifier: NCT06041932 |
Recruitment Status :
Not yet recruiting
First Posted : September 18, 2023
Last Update Posted : October 3, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Cirrhosis | Drug: Carvedilol Drug: Pentoxifylline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pentoxifylline Plus Carvedilol vs Carvedilol Monotherapy in Preventing New Decompensation in Stable Cirrhotic Patients With Prior Decompensation, an Open Label Randomised Control Trial |
Estimated Study Start Date : | November 1, 2023 |
Estimated Primary Completion Date : | August 31, 2024 |
Estimated Study Completion Date : | August 31, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Pentoxiphylline plus Carvedilol
Pentoxiphylline plus Carvedilol
|
Drug: Carvedilol
Carvedilol Drug: Pentoxifylline Pentoxiphylline |
Active Comparator: Carvedilol
PCarvedilol
|
Drug: Carvedilol
Carvedilol |
- Incidence of New onset clinical decompensation (any of overt HE, variceal bleed, clinical jaundice and ascites) at 1 year in two groups. [ Time Frame: 1 year ]
- Precipitants, timing of new-onset decompensation at 6 months in two groups. [ Time Frame: 6 months ]
- Mortality at 6 months [ Time Frame: 6 months ]
- Precipitants, timing of new-onset decompensation at 12 months in two groups [ Time Frame: 12 months ]
- Mortality at 12 months in two groups. [ Time Frame: 12 months ]
- Changes in Liver stiffness measured by Fibroscan at 6 months [ Time Frame: 6 months ]
- Changes in Liver stiffness measured by Fibroscan at 12 months [ Time Frame: 12 months ]
- Change in ESR at 6 months in both groups [ Time Frame: 6 months ]
- Change in CRP at 6 months in both groups [ Time Frame: 6 months ]
- Change in IL 6 at 6 months in both groups [ Time Frame: 6 months ]
- Change in TNF Alpha at 6 months in both groups [ Time Frame: 6 months ]
- Change in Von Willebrand factor at 6 months in both groups [ Time Frame: 6 months ]
- Change in ADAM TS 13 at 6 months in both groups [ Time Frame: 6 months ]
- Change in ESR at 12 months in both groups. [ Time Frame: 12 months ]
- Change in CRP at 12 months in both groups [ Time Frame: 12 months ]
- Change in IL 6 at 12 months in both groups [ Time Frame: 12 months ]
- Change in TNF Alpha at 12 months in both groups [ Time Frame: 12 months ]
- Change in Von Willebrand factor at 12 months in both groups [ Time Frame: 12 months ]
- Change in ADAM TS 13 at 12 months in both groups [ Time Frame: 12 months ]
- Dose of Pentoxifylline and Carvedilol at 6 months. [ Time Frame: 6 months ]
- Dose of Pentoxifylline and Carvedilol at 12 months [ Time Frame: 12 months ]
- Number of patients with change in CTP in both groups. [ Time Frame: 3 month, 6 month, 9 month and at end of 1 year ]
- Number of patients with change in MELD score in both groups. [ Time Frame: 3 month, 6 month, 9 month and at end of 1 year ]MELD minimum value=6 and maximum value=40
- Incidence of Hepatocellular carcinoma at 6 months between two groups. [ Time Frame: 6 months ]
- Incidence of Hepatocellular carcinoma at 12 months between two groups. [ Time Frame: 12 months ]
- Incidence of Portal vein thrombosis at 6 months between two groups. [ Time Frame: 6 months ]
- Incidence of Portal vein thrombosis at 12 months between two groups. [ Time Frame: 12 months ]
- Number of patients with adverse events in both the groups. [ Time Frame: 6 months and 12 months ]
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-70 years
- Cirrhosis with prior clinical decompensation (ascites, Hepatic encephalopathy, Portal Hypertension related bleed)
- No current clinical decompensation (for at least 3 months)
Exclusion Criteria:
- Post TIPS/ BRTO/ SAE patients
- Post renal or liver transplantation
- History of CAD, ischemic cardiomyopathy, PVD, ventricular arrythmia
- Presence of clinical ascites, HE, Jaundice
- Last clinical decompensation within 3 months.
- Ongoing significant alcohol use
- Active HCV/HBV infection (Detectable HCV RNA/ HBV DNA)
- Prior Intolerance to carvedilol and hypersensitivity to Pentoxyfylline
- Use of Pentoxifylline within last 1 month
- AIH/PBC
- Lack of informed consent
- Hepatocellular carcinoma / Portal vein thrombosis/ Budd Chiari Syndrome
- Non-cirrhotic portal hypertension
- Ongoing CAM/Hepatotoxic drug intake
- Known HIV infection
- Pregnant women
- HepatoPulmonary Syndrome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041932
Contact: Dr Jaifrin Daniel, MD | 01146300000 | jdaniel.m07@gmail.com |
India | |
Institute of Liver & Biliary Sciences. | |
New Delhi, Delhi, India, 110070 | |
Contact: Dr Jaifrin Daniel, MD +91-011-46300000 jdaniel.m07@gmail.com |
Responsible Party: | Institute of Liver and Biliary Sciences, India |
ClinicalTrials.gov Identifier: | NCT06041932 |
Other Study ID Numbers: |
ILBS-Cirrhosis-62 |
First Posted: | September 18, 2023 Key Record Dates |
Last Update Posted: | October 3, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Liver Cirrhosis Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases Carvedilol Pentoxifylline Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antihypertensive Agents |
Antioxidants Protective Agents Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Phosphodiesterase Inhibitors Enzyme Inhibitors Platelet Aggregation Inhibitors Radiation-Protective Agents Free Radical Scavengers |