Trial · NCT06505928
A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D
NCT06505928, Phase 2, Completed, Shanghai HEP Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D. Trials, record NCT06505928. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06505928
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D
- NCT number
- NCT06505928
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Shanghai HEP Pharmaceutical Co., Ltd.
- Conditions
- Hepatitis D
- Interventions
- hepalatide
- First posted
- 2024-07-17
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06505928
GET https://conductscience.org/api/trials/v1/NCT06505928/registered