Trial · NCT00006164
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points | 1400 days (3.85 years) post randomization | Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study |
| Primary | Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies | 1400 days (3.85 years) post randomization | For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization) |
| Primary | Death From Any Cause | 1400 days (3.85 years) post randomization | |
| Primary | Development of Hepatocellular Carcinoma (HCC) | 1400 days (3.85 years) post randomization | A diagnosis of development of hepatocellular carcinoma (HCC) was based on either 1. Histology showing HCC (from a biopsy, surgery, or autopsy) or 2. A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to \> 1,000 ng/ml. |
| Primary | Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits | 1400 days (3.85 years) post randomization | Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation) |
| Primary | Variceal Hemorrhage | 1400 days (3.85 years) post randomization | A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified |
| Primary | Ascites | 1400 days (3.85 years) post randomization | Any abdominal fluid which is: 1. Mild, moderate or marked on ultrasound; or 2. Progressive on serial physical examinations; or 3. Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is "mild" ("barely detectable") on physical examination requires ultrasound confirmation that is "mild", "moderate" or "marked" ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition. |
| Primary | Spontaneous Bacterial Peritonitis | 1400 days (3.85 years) post randomization | Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (\> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability. |
| Primary | Hepatic Encephalopathy | 1400 days (3.85 years) post randomization | Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause). |
| Secondary | Serious Adverse Events | 1400 days (3.85 years) post randomization | A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following: 1. Death 2. Is life threatening (risk of death at the time of the event) 3. Requires in-patient hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant disability/incapacity 5. Congenital abnormality or birth defect Trial outcomes (except death) were not considered serious adverse events. |
| Secondary | Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy. | 1400 days (3.85 years) post randomization | Change in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) by assessment of a liver-biopsy specimen obtained during the study (collected at baseline, Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization) |
| Secondary | Presumed Hepatocellular Carcinoma (HCC) | 1400 days (3.85 years) post randomization | Presumed HCC was considered when histology was not available and alpha-fetoprotein (AFP) is \<1000 ng/ml, if: 1. A new hepatic lesion was shown on ultrasound and 1 additional imaging showed a hepatic lesion with characteristics of HCC. 2. AFP\> upper limit of normal (ULN) and 2 imaging studies showed a hepatic lesion with characteristics of HCC. 3. A progressively enlarging hepatic lesion starting as a new defect resulting in patient death. 4. A new hepatic defect with at least 1 characteristic scan and: 1. Increase in size over time or 2. Increasing AFP rising to a level of \>200 ng/ml |
| Secondary | SF-36 Vitality Summary Score | 0.5, 1.5, 2.5, and 3.5 years after randomization | Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Vitality summary score. The SF-36 Vitality summary score is the sum of 4 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline. |
| Secondary | SF-36 Physical Function Summary Score | 0.5, 1.5, 2.5, and 3.5 years after randomization | Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Physical Function summary score. The SF-36 Physical Function summary score is the sum of 10 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline. |
| Secondary | SF-36 Mental Health Summary Score | 0.5, 1.5, 2.5, and 3.5 years after randomization | Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Mental Health summary score. The SF-36 Mental Health summary score is the sum of 5 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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