Trial · NCT06051045
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients with virological response of Hepatitis D virus (HDV) RNA < Limit of Detection (LoD) at FU 12 months after End of Treatment (EOT). | Continuously, up to 12 months | Measurement of virological response of HDV RNA \< LoD |
| Secondary | Percentage of patients with virological response of HDV RNA < LoD | At Baseline, 1 and 3 months, every 3 months after treatment start up to 9 months after date of EOT. | Percentage of patients with virological response of HDV RNA \< LoD at at month 1, 3 and every 3 months after treatment start, and FU month 3, 6, and 9 after EOT. |
| Secondary | Percentage of patients with Hepatitis B surface antigen (HBsAg) < LoD | At Baseline, 1 and 3 months, every 3 months after treatment start up to 12 months after date of EOT. | Percentage of patients with HBsAg \< LoD at month 1 and 3, and every 3 months after treatment start, and FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Change of HBsAg from baseline | From Baseline every 3 months until end of study. | Change of HBsAg from baseline every 3 months during study period. |
| Secondary | Percentage of patients with HDV RNA < LoD or HDV RNA reduction of at least 2 log10 compared to baseline | At Baseline, 1 and 3 months, every 3 months after treatment start up to 12 months after date of EOT. | Percentage of patients with HDV RNA \< LoD or HDV RNA reduction of at least 2 log10 compared to baseline, at month 1 and 3, and every 3 months after treatment start, and FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Percentage of patients with virological relapse, defined as HDV RNA < LoD at EOT and increase of HDV RNA to > LoD after EOT | At 0, 3, 6, 9 and 12 months after date of EOT. | Percentage of patients with virological relapse, defined as HDV RNA \< LoD at EOT and increase of HDV RNA to \> LoD after EOT, after EOT, at FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Percentage of patients with appearance of hepatitis B surface antibody (anti-HBs) | At 0, 3, 6, 9 and 12 months after date of EOT. | Percentage of patients with appearance of hepatitis B surface antibody (anti-HBs) at EOT, and FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Percentage of patients with HBV DNA level < LoD | From Baseline every 3 months until end of study. | Percentage of patients with HBV DNA level \< LoD every 3 months during study period. |
| Secondary | Percentage of patients with biochemical response, defined as normalization of alanine transaminase (ALT) | At Baseline, 1 and 3 months, every 3 months up to 12 months after date of EOT. | Percentage of patients with biochemical response, defined as normalization of alanine transaminase (ALT), at month 1, 3 and every 3 months during treatment, and FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Percentage of patients with combined response, defined as HDV RNA < LoD or HDV RNA reduction of at least 2 log10 compared to baseline and Alanine Aminotransferase (ALT) normalization | At Baseline, at 1, 2 and 3 months, every 3 months up to 12 months after date of EOT. | Percentage of patients with combined response, defined as HDV RNA \< LoD or HDV RNA reduction of at least 2 log10 compared to baseline and ALT normalization, at month 1, 2 and 3, and every 3 months after treatment start, and FU month 3, 6, 9 and 12 after EOT. |
| Secondary | Change of liver elasticity measurement level and percentage of AE of special interest | At Baseline, every 6 months until 12 months after date of EOT. | Change of liver elasticity measurement level from baseline compared to the level at every 6 months during on-treatment, EOT, and FU month 6 and 12 after EOT. Percentage of AE of special interest: 1. Liver-related event, defined as new diagnoses of liver cirrhosis, HCC, or hepatic decompensation (ascites, variceal bleeding or hepatic encephalopathy); 2. Event of ≥ grade 3 hematological AE (in IFN treated); 3. Event of thyroid disorder (in IFN treated); 4. Event of injection site reaction; 5. Event of≥ grade 3 ALT increase. |
| Secondary | Percentage of missed BLV doses during treatment | Continuously during treatment period until date of EOT. | Percentage of missed BLV doses during treatment. |
| Secondary | Percentage of patients with early discontinuation of treatment | Continuously during treatment period until date of EOT. | Percentage of patients with early discontinuation of treatment and the reasons. |
| Secondary | Serious Adverse Events | Continuously during study period until end of study. | Percentage of patients with SAE. |
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/NCT06051045/registered