Trial · NCT06505928
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | compound response | Week 48 | Decrease in HDV RNV by ≥ 2 log10 from baseline and ALT normalization |
| Secondary | HDV RNA below LLOQ | Week 48 | The incidence of subjects with HDV RNA lower than LLOQ. |
| Secondary | Decrease in HDV RNA by ≥ 2 log10 from baseline or undetectable HDV RNA | Week 48 | The incidence of subjects with Decrease in HDV RNA by ≥ 2 log10 from baseline or undetectable HDV RNA |
| Secondary | Decrease in HDV RNA from baseline | Week 48 | HDV RNA reduction from baseline. |
| Secondary | ALT normalization | Week 48 | The rate of ALT relapse in subjects. |
| Secondary | Decrease in ALT from baseline | Week 48 | ALT reduction from baseline. |
| Secondary | Changes in subjects' METAVIR system scores from baseline. | Week 48 | The METAVIR score is a test used to determine the degree of inflammation and necrosis in the liver biopsy, as well as the extent of fibrosis. The degree of liver fibrosis is divided into five grades from F 0 to F4. The degree of inflammatory activity in liver tissue is divided into four grades from A0 to A3. Higher score means worse outcome. When the liver tissue inflammation and necrosis score decreased by ≥2 points compared with baseline (the change of inflammatory activity A value compared with baseline was ≤ -2 points), and there was no increase in liver fibrosis score; Or the liver fibrosis score decreased by ≥1 point (fibrosis stage F value change from baseline ≤ 0 points)，it means Liver tissue response. |
| Secondary | Change in fibrosis 4 (FIB-4) index from baseline | Week 48 | Fibrosis 4（FIB-4）Index is a non-invasive method for assessing liver fibrosis in patients with chronic liver disease. The FIB-4 index is \<1.45, indicating no significant liver fibrosis or only 2nd degree or lower liver fibrosis. And the FIB-4 index\>3.25 indicates that the degree of liver fibrosis is 3-4 or higher. |
| Secondary | Change in Child-Pugh score from baseline | Week 48 | Child-Pugh scores is a test that determines the scope and severity of liver failure as well as the prognosis for the patient. Three categories "A, B and C " indicate the severity of liver breakdown on the Child-Pugh rating scale. The higher the scale, the more serious outcomes. |
| Secondary | Change in Model for End-Stage Liver Disease (MELD) score from baseline | Week 48 | R = 9.6 \\\* ln(serum creatinine in mg/dl) + 3.8 \\\* ln(bilirubin in mg/dl) + 11.2 \\\* ln(INR) + 6.4 \\\* cause (cause: cholestasis and alcoholic cirrhosis = 0, viral and other causes of cirrhosis = 1). The higher the R value, the greater the risk, and the lower the survival rate. |
| Secondary | The incidence rate of Liver-related endpoint events. | Week 240 | The incidence of Liver-related endpoint events such as cirrhosis, hepatic decompensation, HCC, liver transplantation, liver-related death. |
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.
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GET https://conductscience.org/api/trials/v1/NCT06505928/registered