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lack of funding
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The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.
The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.
This study never moved forward due to funding issues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline/Placebo | Experimental | All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days (20-40 treated, 1-20 placebo) with monthly follow up for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pentoxifylline | Drug | daily dosing |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 28 Days | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R Lucey, MD | University of Wisconsin, Madison | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pentoxifylline | All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days |
| FG001 | Placebo | All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pentoxifylline | All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days |
| BG001 | Placebo | All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival at 28 Days | Study was terminated before any data was gathered/analyzed. | Posted | 28 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pentoxifylline |
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Study was terminated before any data was gathered/analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Program Manager - Kelly Richie | University of Wisconsin | 608-262-5404 | kr2@medicine.wisc.edu |
| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Number | 0 |
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | 0 | 0 | 0 | 0 |
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| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |