Trial · NCT02138253
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | 24 months | At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite Since the primary analysis used multiple imputation methodology, the numerator and denominator varied across 20 imputations. |
| Secondary | Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only) | 24 months | At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite |
| Secondary | Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score | 12 months | At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite |
| Secondary | Alanine Aminotransferase (ALT) - Change From Baseline | Baseline and 24 months | Liver function laboratory parameter |
| Secondary | Aspartate Aminotransferase (AST) Change From Baseline | Baseline and 24 months | Liver function laboratory parameter |
| Secondary | Caspase 3/7 Change From Baseline | Baseline and 24 months | Mechanistic biomarker of liver function |
| Secondary | cCK18/M30 Change From Baseline | Baseline and 24 months | Mechanistic biomarker of liver function. |
| Secondary | flCK18/M65 Change From Baseline | Baseline and 24 months | Mechanistic biomarker of liver function |
| Secondary | Ishak Modification of Knodell Histological Activity Index - Interface Hepatitis | 24 months | The Ishak modification of Knodell histological activity index was determined by liver biopsy. Interface hepatitis * 0 = None * 1 = Mild (local, few portal areas) * 2 = Mild/moderate (focal, most portal areas) * 3 = Moderate (continuous around \<50% of tracts or septa) * 4 = Severe (continuous around \>50% of tracts or septa) |
| Secondary | Ishak Modification of Knodell Histological Index - Confluent Necrosis | 24 months | The Ishak modification of Knodell histological activity index will be determined by liver biopsy. The four items and their categorizations scores include: • confluent necrosis * 0 = None * 1 = Focal confluent necrosis * 2 = Zone 3 necrosis in some areas * 3 = Zone 3 necrosis in most areas * 4 = Zone 3 necrosis + occasional portal-central bridging * 5 = Zone 3 necrosis + multiple portal-central bridging * 6 = Panacinar or multiacinar necrosis |
| Secondary | Ishak Modification of Knodell Histological Index - Parenchymal Injury | 24 months | The Ishak modification of Knodell histological activity index will be determined by liver biopsy. • parenchymal injury (focal lytic necrosis, apoptosis and focal inflammation) * 0 = None * 1 = One focus or less per 10× objective * 2 = Two to four foci per 10× objective * 3 = Five to ten foci per 10× objective * 4 = More than ten foci per 10× objective |
| Secondary | Ishak Modification of Knodell Histological Index - Portal Inflammation | 24 months | Portal inflammation * 0 = None * 1 = Mild, some or all portal areas * 2 = Moderate, some or all portal areas * 3 = Moderate/marked, all portal areas * 4 = Marked, all portal areas |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02138253/registered